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A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

Primary Purpose

Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Soticlestat
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dravet Syndrome (DS) focused on measuring Drug Therapy

Eligibility Criteria

2 Years - 56 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Participant must have:

  • Been previously enrolled in soticlestat clinical study TAK-935-3001 (NCT04940624) or TAK-935-3002 (NCT04938427).

Exclusion Criteria:

  1. Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted.
  2. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF.
  3. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.

Sites / Locations

  • Phoenix Childrens Hospital
  • Center For Neurosciences
  • David Geffen School of Medicine at UCLA
  • University of California Benioff Children's HospitalRecruiting
  • Colorado Children's Hospital
  • Pediatric Neurology PA
  • Clinical Integrative Research Center of AtlantaRecruiting
  • Sunrise Pediatric Neurology
  • University of Iowa Hospitals & Clinics - (CRS)Recruiting
  • Midatlantic Epilepsy and Sleep CenterRecruiting
  • Minnesota Epilepsy Group PA
  • Institute of Neurology and Neurosurgery at Saint Barnabas, LLCRecruiting
  • Boston Children's Health Physicians (BCHP)
  • Northwell Health Physician Partners - Neurology at Lenox Hill
  • NYU Comprehensive Epilepsy Center
  • University of Toledo
  • Oregon Health and Science University
  • Children's Hospital of Philadelphia
  • Thomas Jefferson University
  • St. Christopher's Hospital for Children
  • WellSpan Oncology ResearchRecruiting
  • Medical University of South Carolina Children Hospital - PINRecruiting
  • Cook Children's Medical Center - Jane and John Justin Neurosciences CenterRecruiting
  • University of Utah - Primary Children's Hospital - PPDS
  • Seattle Children's Hospital
  • MultiCare Institute for Research & Innovation (Tacoma)
  • Sydney Children's Hospital
  • Queensland Childrens Hospital
  • Austin Hospital
  • Alfred Hospital
  • UZ Antwerpen
  • UZ Antwerpen
  • Centre Neurologique William Lennox
  • Hopital Universitaire des Enfants Reine Fabiola
  • Instituto de Neurologia de Curitiba (INC)
  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
  • Hospital das Clinicas - UNICAMP
  • Universidade Federal de Sao Paulo
  • Universidade de Sao Paulo
  • Child and Family Research Institute
  • Hospital For Sick Children
  • Peking University First HospitalRecruiting
  • Beijing Children's Hospital,Capital Medical UniversityRecruiting
  • Children's Hospital of Chongqing Medical UniversityRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniveristyRecruiting
  • Guangzhou Women And Children's Medical CenterRecruiting
  • Shenzhen Children's HospitalRecruiting
  • Wuhan Childrens hospitalRecruiting
  • Xiangya Hospital of Central South UniversityRecruiting
  • Jiangxi Provincial Children's HospitalRecruiting
  • The First Hospital of Jilin University
  • The First Hospital of Jilin University
  • Children's Hospital of Shanghai
  • Children's Hospital of Fudan University
  • Hopitaux de La Timone
  • CHRU Dijon Hopital General
  • Hopital Roger SalengroRecruiting
  • Hopital Necker - Enfants MaladesRecruiting
  • Hopital Robert DebreRecruiting
  • Alberta Childrens Hospital
  • Klinikum der Johann-Wolfgang Goethe-Universitat
  • Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
  • Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
  • Childrens' Hospital of Athens 'P. and A. Kyriakou'
  • Attikon University General HospitalRecruiting
  • University General Hospital of Larissa
  • Hippokration Hospital
  • Pecsi TudomanyegyetemRecruiting
  • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
  • Bethesda GyermekkorhazRecruiting
  • Orszagos Klinikai Idegtudomanyi IntezetRecruiting
  • Ospedale Bellaria
  • IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
  • Fondazione Policlinico Universitario A Gemelli
  • ASST di Mantova - Azienda Ospedaliera Carlo Poma
  • ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PINRecruiting
  • Aichi Medical University HospitalRecruiting
  • Fukuoka Children's HospitalRecruiting
  • Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
  • Kumamoto-Ezuko Medical Center for The Severely DisabledRecruiting
  • National Hospital Organization Nagasaki Medical CenterRecruiting
  • National Hospital Organization Nishi-Niigata Chuo National HospitalRecruiting
  • Okayama University Hospital
  • Yasuhara Childrens ClinicRecruiting
  • Osaka City General HospitalRecruiting
  • Osaka University HospitalRecruiting
  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological DisordersRecruiting
  • Hokkaido University Hospital
  • National Center of Neurology and PsychiatryRecruiting
  • Childrens University HospitalRecruiting
  • Hospital Civil Fray Antonio Alcalde
  • Kempenhaeghe - PPDSRecruiting
  • Stichting Epilepsie Instellingen NederlandRecruiting
  • Centrum Medyczne PlejadyRecruiting
  • Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
  • Uniwersyteckie Centrum Kliniczne
  • Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Russian National Research Medical University n.a. N.I.Pirogov
  • UGMK-Zdorojie, LLC
  • Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
  • Russian National Research Medical University n.a. N.I.Pirogov
  • Tyumen State Medical Academy
  • Clinic for Neurology and Psychiatry for Children and YouthRecruiting
  • Mother and Child Health Care Institute of Serbia Dr Vukan CupicRecruiting
  • University Clinical Center NisRecruiting
  • Children and Youth Health Care Institute of VojvodinaRecruiting
  • Clinica Universidad NavarraRecruiting
  • Hospital Regional Universitario de Malaga Hospital General
  • Hospital Universitario Vall d'Hebron - PPDSRecruiting
  • Hospital Vithas La Salud
  • Centro de Neurologia Avanzada
  • Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
  • Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
  • Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
  • Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
  • CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
  • SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Soticlestat

Arm Description

Participants with DS and LGS will receive:Participants weighing <45kg:Soticlestat,mini-tablets,titrated from lower dose level(60mg to 140mg) to higher dose(100mg to 200mg) twice daily(BID),based on body weight,orally/via enteral feeding tubes including but not limited to nasogastric(NG)-tube,gastrostomy tube(G-tube),MIC-KEY button,upto 2 weeks in Titration Period. Will continue to receive dose they are on at end of Titration Period,for approximately 4 years in Maintenance Period.Dose will be tapered down to lower dose(not less than lowest dose level based on weight)every 3 days until study drug is discontinued(upto 1week) in Taper Period.Participants weighing ≥45kg/adults:Soticlestat mini-tablets/tablets with starting dose of 200mg BID followed by 300mg BID,up to 2 weeks in Titration Period.Will continue to receive 300mg BID for approximately 4 years in Maintenance Period.Dose will be tapered down upto 100mg every 3 days until study drug is discontinued(up to 1 week) in Taper Period.

Outcomes

Primary Outcome Measures

Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation.
Change from Baseline in Body Weight for All Age Groups
Change from Baseline in Height for All Age Groups
Absolute Value for Tanner Stage for Children 6 to 17 Years of Age During the Study
Tanner assessment score is used to document the stage of development of puberty by assessing the secondary sexual characteristics, rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study

Secondary Outcome Measures

Percent Change from Baseline in Total Seizure Frequency per 28 Days for DS and LGS Participants
Seizure frequency per 28 days is defined as total number of seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline is defined as (frequency of seizures per 28 days during Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100.
Percent Change from Baseline in Convulsive Seizure Frequency per 28 Days in DS Cohort
Convulsive seizure frequency per 28 days is defined as total number of convulsive seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of convulsive seizures per 28 days during Treatment Period - frequency of convulsive seizures per 28 days at Baseline) divided by the frequency of convulsive seizures per 28 days at Baseline multiplied by 100.
Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency per 28 Days in LGS Cohort
MMD seizure frequency per 28 days is defined as total number of MMD seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of MMD seizures per 28 days during the Treatment Period - frequency of MMD seizures per 28 days at Baseline) divided by the frequency of MMD seizures per 28 days at Baseline multiplied by 100.
Clinical Global Impression of Improvement (CGI-I) Score
The CGI-I Clinician is a 7-point Likert scale that the investigator uses to rate a participant's change (improvement) in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.
Caregiver Global Impression of Improvement (Care GI-I) Score
The Care GI-I is a 7-point Likert scale that the caregiver uses to rate improvement in overall seizure control, behavior, safety and tolerability after the initiation of study drug relative to Baseline (before treatment with study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). The parent/caregiver will complete the Care GI-I via interview. Higher score will indicate worse symptoms.
CGI-I Seizure Intensity and Duration Score
The CGI-I seizure intensity and duration instrument is used by the parent/caregiver to rate improvement in intensity and duration of convulsive seizures (DS Cohort) or MMD seizures (LGS Cohort) from Baseline. The participant's symptoms will be rated on 7-point scale as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.
CGI-I Nonseizure Symptoms Score
The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator uses to rate improvement in the symptoms and impacts in select nonseizure domains since initiating the study drug. The participant will be rated on 7-point scale by the investigator as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). At Baseline, a symptoms form is completed by the clinician in collaboration with the primary caregiver to assess the participants status based on the presence of any nonseizure symptoms. Higher score will indicate worse symptoms.
Change in Quality of Life Inventory-Disability (QI-Disability) Score
The QI-Disability tool is a parent/caregiver-reported questionnaire that evaluates quality of life in children with intellectual disabilities. It contains 32 items covering 6 domains of quality of life: physical health, positive emotions, negative emotions, social interaction, leisure and the outdoors, and independence. Scores are from a 5-point Likert scale and then are transformed to a scale of 0 to 100. Possible scores range from 0-100, with higher scores indicating better quality of life.

Full Information

First Posted
December 15, 2021
Last Updated
June 23, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT05163314
Brief Title
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
Official Title
A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
May 22, 2026 (Anticipated)
Study Completion Date
May 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.
Detailed Description
The drug being tested in this study is called soticlestat (TAK-935). Soticlestat administered long-term in pediatric and adult participants who participated in an antecedent soticlestat Phase 3 clinical study will be assessed for additional safety and tolerability data along with efficacy analysis, as well as palatability and acceptability of soticlestat in the pediatric population. The study will enroll approximately 400 participants. All participants will receive soticlestat based on their weight in the 2-week Titration Period (for participants who roll over from an antecedent double-blind study). Following the Titration Period, participants will continue to receive the same dose in the Maintenance Period. At the end of maintenance period, the dose will be down-tapered (unless already at the lowest dose) and then stopped. Participants not tolerating minimum dose of 100 mg twice a day (BID) will be discontinued from the study. This multi-center trial will be conducted worldwide. The overall time to participate in the study will be approximately 4 years, or until the study is stopped at the discretion of the sponsor, or the product is approved and launched. Participants who discontinue study drug treatment before the completion of the study, will continue to be followed per protocol and maintain a daily seizure diary until the final follow-up phone call.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Soticlestat
Arm Type
Experimental
Arm Description
Participants with DS and LGS will receive:Participants weighing <45kg:Soticlestat,mini-tablets,titrated from lower dose level(60mg to 140mg) to higher dose(100mg to 200mg) twice daily(BID),based on body weight,orally/via enteral feeding tubes including but not limited to nasogastric(NG)-tube,gastrostomy tube(G-tube),MIC-KEY button,upto 2 weeks in Titration Period. Will continue to receive dose they are on at end of Titration Period,for approximately 4 years in Maintenance Period.Dose will be tapered down to lower dose(not less than lowest dose level based on weight)every 3 days until study drug is discontinued(upto 1week) in Taper Period.Participants weighing ≥45kg/adults:Soticlestat mini-tablets/tablets with starting dose of 200mg BID followed by 300mg BID,up to 2 weeks in Titration Period.Will continue to receive 300mg BID for approximately 4 years in Maintenance Period.Dose will be tapered down upto 100mg every 3 days until study drug is discontinued(up to 1 week) in Taper Period.
Intervention Type
Drug
Intervention Name(s)
Soticlestat
Other Intervention Name(s)
TAK-935
Intervention Description
Soticlestat mini-tablets or tablets
Primary Outcome Measure Information:
Title
Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE)
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Time Frame
Up to 4 years
Title
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Description
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation.
Time Frame
Up to 4 years
Title
Change from Baseline in Body Weight for All Age Groups
Time Frame
Up to 4 years
Title
Change from Baseline in Height for All Age Groups
Time Frame
Up to 4 years
Title
Absolute Value for Tanner Stage for Children 6 to 17 Years of Age During the Study
Description
Tanner assessment score is used to document the stage of development of puberty by assessing the secondary sexual characteristics, rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Time Frame
Up to 4 years
Title
Absolute Value for Insulin-like Growth Factor 1 (IGF-1) for Children 2 to 17 Years of Age During the Study
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in Total Seizure Frequency per 28 Days for DS and LGS Participants
Description
Seizure frequency per 28 days is defined as total number of seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline is defined as (frequency of seizures per 28 days during Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100.
Time Frame
Up to 4 years
Title
Percent Change from Baseline in Convulsive Seizure Frequency per 28 Days in DS Cohort
Description
Convulsive seizure frequency per 28 days is defined as total number of convulsive seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of convulsive seizures per 28 days during Treatment Period - frequency of convulsive seizures per 28 days at Baseline) divided by the frequency of convulsive seizures per 28 days at Baseline multiplied by 100.
Time Frame
Up to 4 years
Title
Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency per 28 Days in LGS Cohort
Description
MMD seizure frequency per 28 days is defined as total number of MMD seizures reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline will be defined as (frequency of MMD seizures per 28 days during the Treatment Period - frequency of MMD seizures per 28 days at Baseline) divided by the frequency of MMD seizures per 28 days at Baseline multiplied by 100.
Time Frame
Up to 4 years
Title
Clinical Global Impression of Improvement (CGI-I) Score
Description
The CGI-I Clinician is a 7-point Likert scale that the investigator uses to rate a participant's change (improvement) in overall seizure control, behavior, safety and tolerability, after the initiation of study drug relative to Baseline (before treatment with study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.
Time Frame
Up to 4 years
Title
Caregiver Global Impression of Improvement (Care GI-I) Score
Description
The Care GI-I is a 7-point Likert scale that the caregiver uses to rate improvement in overall seizure control, behavior, safety and tolerability after the initiation of study drug relative to Baseline (before treatment with study drug). The participant will be rated as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). The parent/caregiver will complete the Care GI-I via interview. Higher score will indicate worse symptoms.
Time Frame
Up to 4 years
Title
CGI-I Seizure Intensity and Duration Score
Description
The CGI-I seizure intensity and duration instrument is used by the parent/caregiver to rate improvement in intensity and duration of convulsive seizures (DS Cohort) or MMD seizures (LGS Cohort) from Baseline. The participant's symptoms will be rated on 7-point scale as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). Higher score will indicate worse symptoms.
Time Frame
Up to 4 years
Title
CGI-I Nonseizure Symptoms Score
Description
The CGI-I nonseizure symptoms instrument is a series of single-item assessments that the investigator uses to rate improvement in the symptoms and impacts in select nonseizure domains since initiating the study drug. The participant will be rated on 7-point scale by the investigator as follows: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse). At Baseline, a symptoms form is completed by the clinician in collaboration with the primary caregiver to assess the participants status based on the presence of any nonseizure symptoms. Higher score will indicate worse symptoms.
Time Frame
Up to 4 years
Title
Change in Quality of Life Inventory-Disability (QI-Disability) Score
Description
The QI-Disability tool is a parent/caregiver-reported questionnaire that evaluates quality of life in children with intellectual disabilities. It contains 32 items covering 6 domains of quality of life: physical health, positive emotions, negative emotions, social interaction, leisure and the outdoors, and independence. Scores are from a 5-point Likert scale and then are transformed to a scale of 0 to 100. Possible scores range from 0-100, with higher scores indicating better quality of life.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Participant must have: Been previously enrolled in a phase 3 soticlestat clinical study. Exclusion Criteria: Unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, ophthalmologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, endocrine disease, malignancy including progressive tumors, or other abnormality that may impact the ability to participate in the study or that may potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the medical monitor may be warranted. Abnormal and clinically significant ECG abnormality at Visit 1 including QT interval with Fridericia correction method (QTcF) >450 milliseconds (ms) confirmed with a repeat ECG using manual measurement of QTcF. Participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Participants who have positive answers on item numbers 4 or 5 on the CSSRS before dosing are excluded. This scale will only be administered to participants aged ≥6 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
602-933-0970
Email
awilfong@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Angus Wilfong
Facility Name
Center For Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
520-320-2147
Email
dtalwar@neurotucson.com
First Name & Middle Initial & Last Name & Degree
Dinesh Talwar
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
310-825-6196
Email
shussain@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Shaun Hussain
Facility Name
University of California Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
415-353-8440
Email
joseph.sullivan@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Joseph Sullivan
Facility Name
Colorado Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
720-777-8499
Email
scott.demarest@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Scott Demarest
Facility Name
Pediatric Neurology PA
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
407-293-1122
Email
rgdavis@pediatricneurologypa.com
First Name & Middle Initial & Last Name & Degree
Ronald Davis
Facility Name
Clinical Integrative Research Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
678-705-7341
Email
rflamini@pandaneuro.com
First Name & Middle Initial & Last Name & Degree
Julio Flamini
Facility Name
Sunrise Pediatric Neurology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
678-606-5700
Email
cfrazier@sunriseneurology.com
First Name & Middle Initial & Last Name & Degree
Cherise Frazier
Facility Name
University of Iowa Hospitals & Clinics - (CRS)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
319-384-5437
Email
michael-ciliberto@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Michael Ciliberto
Facility Name
Midatlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
301-530-9744
Email
kleinp@epilepsydc.com
First Name & Middle Initial & Last Name & Degree
Pavel Klein
Facility Name
Minnesota Epilepsy Group PA
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
651-241-5290
Email
nagarwal@mnepilepsy.net
First Name & Middle Initial & Last Name & Degree
Nitin Agarwal
Facility Name
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
973-322-7580
Email
rgoldberg@inst-neuro.com
First Name & Middle Initial & Last Name & Degree
Rina Goldberg
Facility Name
Boston Children's Health Physicians (BCHP)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
212-844-6944
Email
steven_wolf@bchphysicians.org
First Name & Middle Initial & Last Name & Degree
Steven Wolf
Facility Name
Northwell Health Physician Partners - Neurology at Lenox Hill
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
646-558-0842
Email
rkuzniecky@northwell.edu
First Name & Middle Initial & Last Name & Degree
Ruben Kuzniecky
Facility Name
NYU Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
646-558-0842
Email
Orrin.Devinsky@nyulangone.org; Od4@nyu.edu
First Name & Middle Initial & Last Name & Degree
Orrin Devinsky
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
419-383-3544
Email
imran.ali@utoledo.edu
First Name & Middle Initial & Last Name & Degree
Imran Ali
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
503-494-5856
Email
robertco@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Colin Roberts
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-590-1719
Email
marshe@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Eric Marsh
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-955-1222
Email
michael.sperling@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Michael Sperling
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-427-5470
Email
ignacio.valencia@drexelmed.edu
First Name & Middle Initial & Last Name & Degree
Ignacio Valencia
Facility Name
WellSpan Oncology Research
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
717-851-5503
Email
tbarron@wellspan.org
First Name & Middle Initial & Last Name & Degree
Todd Barron
Facility Name
Medical University of South Carolina Children Hospital - PIN
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
843-792-3221
Email
halfordj@musc.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Halford
Facility Name
Cook Children's Medical Center - Jane and John Justin Neurosciences Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
682-885-2500
Email
scott.perry@cookchildrens.org
First Name & Middle Initial & Last Name & Degree
Michael Perry
Facility Name
University of Utah - Primary Children's Hospital - PPDS
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
801-587-7575
Email
matthew.sweney@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Matthew Sweney
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
206-987-2708
Email
russ.saneto@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Russell Saneto
Facility Name
MultiCare Institute for Research & Innovation (Tacoma)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98402
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
253-403-7251
Email
saphillips@multicare.org
First Name & Middle Initial & Last Name & Degree
Steven Phillips
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61293821658
Email
michael.cardamone@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Michael Cardamore
Facility Name
Queensland Childrens Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61730621957
Email
kate.riney@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Catherine Riney
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61390357112
Email
i.scheffer@unimelb.edu.au
First Name & Middle Initial & Last Name & Degree
Ingrid Scheffer
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61390762000
Email
te.obrien@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Terence OBrien
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3234660610
Email
berten.ceulemans@uza.be
First Name & Middle Initial & Last Name & Degree
Berten Ceulemans
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3238213420
Email
an-sofie.schoonjans@uza.be
First Name & Middle Initial & Last Name & Degree
An-Sofie Schoonjans
Facility Name
Centre Neurologique William Lennox
City
Ottignies-Louvain-la-Neuve
State/Province
Brabant Wallon
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3210430211
Email
pascal.vrielynck@chnwl.be
First Name & Middle Initial & Last Name & Degree
Pascal Vrielynck
Facility Name
Hopital Universitaire des Enfants Reine Fabiola
City
Brussel
State/Province
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3224773174
Email
alec.aeby@huderf.be
First Name & Middle Initial & Last Name & Degree
Alec Aeby
Facility Name
Instituto de Neurologia de Curitiba (INC)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81210-310
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+554130288545
Email
pkowacs@gmail.com
First Name & Middle Initial & Last Name & Degree
Pedro Kowacs
Facility Name
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+555133205133
Email
apalmini@uol.com.br
First Name & Middle Initial & Last Name & Degree
Andre Palmini
Facility Name
Hospital das Clinicas - UNICAMP
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-887
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+551935217372
Email
fcendes@unicamp.br
First Name & Middle Initial & Last Name & Degree
Fernando Cendes
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023-900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
5511991816889
Email
lauragui@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Maria Guilhoto
Facility Name
Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+551130696000
Email
kettevalente@msn.com
First Name & Middle Initial & Last Name & Degree
Kette Dualibi Ramos Valente
Facility Name
Child and Family Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4H4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(604) 875-2612
Email
cyrus.boelman@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Cyrus Boelman
Facility Name
Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
(416) 813-7037
Email
cecil.hahn@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Cecil Hahn
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613701398992
Email
jiangyuwu@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yuwu Jiang
Facility Name
Beijing Children's Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+861059616161
Email
13910150389@163.com
First Name & Middle Initial & Last Name & Degree
Fang Fang
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+868888888888
Email
neurojiang@gmail.com
First Name & Middle Initial & Last Name & Degree
Li Jiang
Facility Name
The Second Affiliated Hospital of Guangzhou Medical Univeristy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+862034152626
Email
wpliao@163.net
First Name & Middle Initial & Last Name & Degree
Wei-Ping Liao
Facility Name
Guangzhou Women And Children's Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618902268798
Email
gzchcwx@126.com
First Name & Middle Initial & Last Name & Degree
Wen-Xiong Chen
Facility Name
Shenzhen Children's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518026
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8675583936101
Email
liaojianxiang@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Jianxiang Liao
Facility Name
Wuhan Childrens hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613971616910
Email
bloveriver@163.com
First Name & Middle Initial & Last Name & Degree
Dan Sun
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613548966986
Email
pengjing4346@163.com
First Name & Middle Initial & Last Name & Degree
Jing Peng
Facility Name
Jiangxi Provincial Children's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613077900710
Email
zhongjm@163.com
First Name & Middle Initial & Last Name & Degree
Jianmin Zhong
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613578652528
Email
jackyliangjm@163.com
First Name & Middle Initial & Last Name & Degree
Jianmin Liang
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8615804301796
Email
linweihong321@126.com
First Name & Middle Initial & Last Name & Degree
Weihong Lin
Facility Name
Children's Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618930590051
Email
chenyc@shchildren.com.cn
First Name & Middle Initial & Last Name & Degree
Yucai Chen
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618017591161
Email
szzhou@shmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shui-Zhen Zhou
Facility Name
Hopitaux de La Timone
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33491384310
Email
mathieu.milh@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Mathieu Milh
Facility Name
CHRU Dijon Hopital General
City
Dijon
State/Province
Cote-d'Or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33380293754
Email
martine.lemesle@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Martine Lemesle-Martin
Facility Name
Hopital Roger Salengro
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33241354445
Email
sylvie.nguyenthetich@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Sylvie Nguyen
Facility Name
Hopital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33144494854
Email
rima.nabbout@nck.aphp.fr
First Name & Middle Initial & Last Name & Degree
Rima El Nabbout-Tarantino
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+33140033667
Email
stephane.auvin@aphp.fr
First Name & Middle Initial & Last Name & Degree
Stephane Auvin
Facility Name
Alberta Childrens Hospital
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4976127053660
Email
julia.jacobs@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Julia Jacobs-LeVan
Facility Name
Klinikum der Johann-Wolfgang Goethe-Universitat
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4964215865348
Email
rosenow@med.uni-frankfurt.de
First Name & Middle Initial & Last Name & Degree
Felix Rosenow
Facility Name
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33617
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4952177278804
Email
christian.brandt@mara.de
First Name & Middle Initial & Last Name & Degree
Christian Brandt
Facility Name
Kleinwachau Sachsisches Epilepsiezentrum Radeberg Gemeinnutzige Gmbh
City
Radeberg
State/Province
Sachsen
ZIP/Postal Code
01454
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+4935284311680
Email
t.mayer@kleinwachau.de
First Name & Middle Initial & Last Name & Degree
Thomas Mayer
Facility Name
Childrens' Hospital of Athens 'P. and A. Kyriakou'
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+306974093905
Email
vartzelius@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Georgios Vartzelis
Facility Name
Attikon University General Hospital
City
Chaidari
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302105831269
Email
argidino@yahoo.com
First Name & Middle Initial & Last Name & Degree
Argirios Dinopoulos
Facility Name
University General Hospital of Larissa
City
Larisa
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302413501137
Email
ebsdar@gmail.com
First Name & Middle Initial & Last Name & Degree
Efthimios Dardiotis
Facility Name
Hippokration Hospital
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+302310892437
Email
jeff@med.auth.gr
First Name & Middle Initial & Last Name & Degree
Dimitrios Zafeiriou
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7623
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3672535900
Email
hollody.katalin@pte.hu
First Name & Middle Initial & Last Name & Degree
Katalin Hollody
Facility Name
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3613450613
Email
altmann.anna@yahoo.com
First Name & Middle Initial & Last Name & Degree
Anna Altmann
Facility Name
Bethesda Gyermekkorhaz
City
Budapest
ZIP/Postal Code
1143
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+3614222873
Email
fog.andras@gmail.com
First Name & Middle Initial & Last Name & Degree
Andras Fogarasi
Facility Name
Orszagos Klinikai Idegtudomanyi Intezet
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+36306894111
Email
fabo.daniel@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel Fabo
Facility Name
Ospedale Bellaria
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390514966937
Email
francesca.bisulli@unibo.it
First Name & Middle Initial & Last Name & Degree
Francesca Bisulli
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
City
Roma
State/Province
Lazio
ZIP/Postal Code
00197
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390668592645
Email
nicola.specchio@opbg.net
First Name & Middle Initial & Last Name & Degree
Nicola Specchio
Facility Name
Fondazione Policlinico Universitario A Gemelli
City
Roma
State/Province
Lazio
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390630154901
Email
domenicaimmacolata.battaglia@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Domenica Battaglia
Facility Name
ASST di Mantova - Azienda Ospedaliera Carlo Poma
City
Mantova
State/Province
Lombardia
ZIP/Postal Code
46100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390376201373
Email
francesca.beccaria@asst-mantova.it
First Name & Middle Initial & Last Name & Degree
Francesca Beccaria
Facility Name
ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390382380289
Email
valentina.degiorgis@mondino.it
First Name & Middle Initial & Last Name & Degree
Valentina De Giorgis
Facility Name
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+390555662573
Email
renzo.guerrini@meyer.it
First Name & Middle Initial & Last Name & Degree
Renzo Guerrini
Facility Name
Aichi Medical University Hospital
City
Nagakute-Shi
State/Province
Aiti
ZIP/Postal Code
480-1195
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81561623311
Email
okumura.akihisa.479@mail.aichi-med-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Akihisa Okumura
Facility Name
Fukuoka Children's Hospital
City
Fukuoka-Shi
State/Province
Hukuoka
ZIP/Postal Code
813-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81926827000
Email
kira.r@fcho.jp
First Name & Middle Initial & Last Name & Degree
Ryutaro Kira
Facility Name
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
232-0066
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81457112351
Email
tgoto@kcmc.jp
First Name & Middle Initial & Last Name & Degree
Tomohide Goto
Facility Name
Kumamoto-Ezuko Medical Center for The Severely Disabled
City
Kumamoto-Shi
State/Province
Kumamoto
ZIP/Postal Code
862-0947
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81963700501
Email
T-ishitsu@ezuko.jp
First Name & Middle Initial & Last Name & Degree
Takateru Ishitsu
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Omura-Shi
State/Province
Nagasaki
ZIP/Postal Code
856-0835
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81957523121
Email
honda.ryoko.gu@mail.hosp.go.jp
First Name & Middle Initial & Last Name & Degree
Ryoko Honda
Facility Name
National Hospital Organization Nishi-Niigata Chuo National Hospital
City
Niigata-Shi
State/Province
Niigata
ZIP/Postal Code
950-2074
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81252653171
Email
tohyama.jun.um@mail.hosp.go.jp
First Name & Middle Initial & Last Name & Degree
Jun Tohyama
Facility Name
Okayama University Hospital
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81862357991
Email
k_koba@md.okayama-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Katsuhiro Kobayashi
Facility Name
Yasuhara Childrens Clinic
City
Neyagawa-Shi
State/Province
Osaka
ZIP/Postal Code
572-0085
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81728322211
Email
akihiro-yasuhara@car.ocn.ne.jp
First Name & Middle Initial & Last Name & Degree
Akihiro Yasuhara
Facility Name
Osaka City General Hospital
City
Osaka-Shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81669291221
Email
sokazaki2009@gmail.com
First Name & Middle Initial & Last Name & Degree
Shin Okazaki
Facility Name
Osaka University Hospital
City
Suita-Shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81668795111
Email
nabatames@ped.med.osaka-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Shin Nabatame
Facility Name
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
City
Shizuoka-Shi
State/Province
Sizuoka
ZIP/Postal Code
420-0953
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81542455446
Email
s.hizuokasan3@googlemail.com
First Name & Middle Initial & Last Name & Degree
Tokito Yamaguchi
Facility Name
Hokkaido University Hospital
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81117067028
Email
siraisi@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Hideaki Shiraishi
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira-Shi
State/Province
Tokyo
ZIP/Postal Code
187-0031
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+81423462190
Email
nakagawa@ncnp.go.jp
First Name & Middle Initial & Last Name & Degree
Eiji Nakagawa
Facility Name
Childrens University Hospital
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+37129535342
Email
dr.rozentals@inbox.lv
First Name & Middle Initial & Last Name & Degree
Guntis Rozentals
Facility Name
Hospital Civil Fray Antonio Alcalde
City
El Retiro
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+5213331907661
Email
dr_ceja@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hugo Ceja Moreno
Facility Name
Kempenhaeghe - PPDS
City
Heeze
State/Province
Noord-Brabant
ZIP/Postal Code
5591 VE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+31402279203
Email
majoiem@kempenhaeghe.nl
First Name & Middle Initial & Last Name & Degree
Marian Majoie
Facility Name
Stichting Epilepsie Instellingen Nederland
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 BV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+31683709913
Email
bgunning@sein.nl
First Name & Middle Initial & Last Name & Degree
Boudewijn Gunning
Facility Name
Centrum Medyczne Plejady
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48123535555
Email
marta.zolnowska@gmail.com
First Name & Middle Initial & Last Name & Degree
Marta Zolnowska
Facility Name
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-091
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48606445668
Email
sergiusz.jozwiak@gmail.com
First Name & Middle Initial & Last Name & Degree
Sergiusz Jozwiak
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48583492396
Email
mmazur@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Maria Mazurkiewicz-Beldzinska
Facility Name
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+48618691613
Email
bstein@ump.edu.pl
First Name & Middle Initial & Last Name & Degree
Barbara Steinborn
Facility Name
Russian National Research Medical University n.a. N.I.Pirogov
City
Moscow
State/Province
Moskva
ZIP/Postal Code
117437
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+74959369452
Email
zavadenko@mail.ru
First Name & Middle Initial & Last Name & Degree
Nikolay Zavadenko
Facility Name
UGMK-Zdorojie, LLC
City
Ekaterinburg
ZIP/Postal Code
620144
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+73432830808
Email
trtomenko@yandex.ru
First Name & Middle Initial & Last Name & Degree
Tatiana Tomenko
Facility Name
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+79080160312
Email
mart2802@yandex.ru
First Name & Middle Initial & Last Name & Degree
Diana Dmitrenko
Facility Name
Russian National Research Medical University n.a. N.I.Pirogov
City
Moscow
ZIP/Postal Code
125412
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+79161888426
Email
edbelous56@gmail.com
First Name & Middle Initial & Last Name & Degree
Elena Belousova
Facility Name
Tyumen State Medical Academy
City
Tyumen'
ZIP/Postal Code
625023
Country
Russian Federation
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+79829722309
Email
olga-rakh@yandex.ru
First Name & Middle Initial & Last Name & Degree
Olga Rakhmanina
Facility Name
Clinic for Neurology and Psychiatry for Children and Youth
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+381638679625
Email
milan.borkovic.npk@gmail.com
First Name & Middle Initial & Last Name & Degree
Milan Borkovic
Facility Name
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+381113108287
Email
ruzica.kravljanac@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruzica Kravljanac
Facility Name
University Clinical Center Nis
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+381642572634
Email
tosic.tatjana@gmail.com
First Name & Middle Initial & Last Name & Degree
Tatjana Tosic
Facility Name
Children and Youth Health Care Institute of Vojvodina
City
Novi Sad
ZIP/Postal Code
21 000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+38121424385
Email
mkp.marija@gmail.com
First Name & Middle Initial & Last Name & Degree
Marija Knezevic-Pogancev
Facility Name
Clinica Universidad Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+349482554004251
Email
rsanchezc@unav.es
First Name & Middle Initial & Last Name & Degree
Rocio Sanchez-Carpintero
Facility Name
Hospital Regional Universitario de Malaga Hospital General
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34671562365
Email
pedro.serrano.c@gmail.com
First Name & Middle Initial & Last Name & Degree
Pedro Serrano
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34934894257
Email
mtoledo@vhebron.net
First Name & Middle Initial & Last Name & Degree
Manuel Toledo
Facility Name
Hospital Vithas La Salud
City
Granada
ZIP/Postal Code
18008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34958023352
Email
jucasan9@gmail.com
First Name & Middle Initial & Last Name & Degree
Juan Sanchez Alvarez
Facility Name
Centro de Neurologia Avanzada
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34955277751
Email
uranganeuro@gmail.com
First Name & Middle Initial & Last Name & Degree
Juan Jesus Rodriguez Uranga
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+34961244161
Email
vevillanuevah@yahoo.es
First Name & Middle Initial & Last Name & Degree
Vicente Villanueva
Facility Name
Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC
City
Dnipro
State/Province
Dnipropetrovs'ka Oblast
ZIP/Postal Code
49100
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380676220775
Email
grial2401@gmail.com
First Name & Middle Initial & Last Name & Degree
Alla Kyrychenko
Facility Name
Communal Non-profit Enterprise Dnipro City Children Clinical Hospital #5 of DCC
City
Dnipro
State/Province
Dnipropetrovs'ka Oblast
ZIP/Postal Code
49101
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380567446150
Email
iryna.maked@gmail.com
First Name & Middle Initial & Last Name & Degree
Iryna Makedonska
Facility Name
Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380505624064
Email
delwa@ukr.net
First Name & Middle Initial & Last Name & Degree
Dmytro Delva
Facility Name
CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA
City
Kyiv
ZIP/Postal Code
4080
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380679904374
Email
vkharytonov69@gmail.com
First Name & Middle Initial & Last Name & Degree
Volodymyr Kharytonov
Facility Name
SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr
City
Kyiv
ZIP/Postal Code
4209
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+380444121068
Email
ukrmedcentr@gmail.com
First Name & Middle Initial & Last Name & Degree
Volodymyr Martyniuk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/f1ef0bf231f449b6?idFilter=%5B%22TAK-935-3003%22%5D
Description
To obtain more information on the study, click here/on this link.

Learn more about this trial

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

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