Back to resultsA Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Primary Purpose
Narcolepsy Type 1, Narcolepsy Type 2
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAK-861
Sponsored by
About this trial
This is an interventional treatment trial for Narcolepsy Type 1 focused on measuring Drug Therapy
Eligibility Criteria
Inclusion criteria: 1. Participant with a diagnosis of narcolepsy who has completed a controlled study with TAK-861 (including participants diagnosed with NT1 or NT2) and for whom the investigator has no clinical objection to their enrollment. Exclusion criteria: Participant has a moderate or severe ongoing treatment emergent adverse event (TEAE) related to the study drug from the parent study or discontinued because of TEAEs in the parent study. Participant has a positive urine screen for drugs of abuse (findings confirmed) and/or positive alcohol test during any visit in their prior TAK-861 study, or during the screening period for participants with a dosing gap. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) on any visit in the parent TAK-861 study, or has positive answers on item 4 or 5 on the Screening/Baseline C-SSRS Lifetime (based on the past year) during the screening assessment for participants with a dosing gap. Participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) at multiple visits in the parent study and the findings are of clinical significance, per investigator or sponsor opinion, or ALT/AST >1.5 times ULN during the screening period for participants with a dosing gap. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS). Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention). Participant has epilepsy or history of seizure. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications. Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure. Participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment, or basal cell skin cancer.
Sites / Locations
- Sleep Disorders Center of AlabamaRecruiting
- Stanford Center for Sleep Sciences and MedicineRecruiting
- SDS Clinical Trials, Inc.Recruiting
- Delta Waves LLC - Hunt - PPDSRecruiting
- Florida Pediatric Research InstituteRecruiting
- Neurotrials ResearchRecruiting
- Georgia Neuro CenterRecruiting
- Neurocare IncRecruiting
- Henry Ford Medical Center - ColumbusRecruiting
- Research Carolina EliteRecruiting
- ARSM Research, LLCRecruiting
- CTI Research CenterRecruiting
- Intrepid ResearchRecruiting
- The Cleveland Clinic FoundationRecruiting
- Ohio Sleep Medicine InstituteRecruiting
- Medical University of South Carolina - PPDSRecruiting
- Bogan Sleep Consultants, LLCRecruiting
- Sleep Therapy and Research CenterRecruiting
- Children's Specialty GroupRecruiting
- Woolcock Institute of Medical ResearchRecruiting
- Terveystalo Helsinki Sleep ClinicRecruiting
- Hopital Pierre-Paul RiquetRecruiting
- CHU Gui De ChauliacRecruiting
- CHU de GrenobleRecruiting
- Hopital de la Pitie SalpetriereRecruiting
- Universitaet Regensburg am BezirksklinikumRecruiting
- Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbHRecruiting
- Charite - Universitatsmedizin BerlinRecruiting
- Klinische Forschung HamburgRecruiting
- Fondazione PTV Policlinico Tor VergataRecruiting
- Istituto Neurologico Mediterraneo NeuromedRecruiting
- Ospedale BellariaRecruiting
- Kurume University HospitalRecruiting
- Howakai Kuwamizu HospitalRecruiting
- YOU ARIYOSHI Sleep ClinicRecruiting
- Gokeikai Osaka Kaisei HospitalRecruiting
- Koishikawa Tokyo HospitalRecruiting
- Aichi Medical University HospitalRecruiting
- Kempenhaeghe - PPDSRecruiting
- Slaap-Waakcentrum SEIN HeemstedeRecruiting
- University of OsloRecruiting
- Hospital Universitario Araba SantiagoRecruiting
- Hospital General de CastelloRecruiting
- Hospital de La RiberaRecruiting
- Hospital Universitario Vall d'Hebron - PPDSRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Instituto de Investigaciones del SuenoRecruiting
- Hospital Vithas Madrid Arturo SoriaRecruiting
- Sahlgrenska University HospitalRecruiting
- Klinik Barmelweid AGRecruiting
- Neurocenter of Southern SwitzerlandRecruiting
- Universitaetsspital Bern - InselspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
TAK-861 Dose 1
TAK-861 Dose 2
TAK-861 Dose 3
TAK-861 Dose 4
Arm Description
Participants will receive TAK-861 dose 1 for up to 104 weeks.
Participants will receive TAK-861 dose 2 for up to 104 weeks.
Participants will receive TAK-861 dose 3 for up to 104 weeks.
Participants will receive TAK-861 dose 4 for up to 104 weeks.
Outcomes
Primary Outcome Measures
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
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 (e.g., 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 defined as an adverse event with an onset that occurs after receiving study drug.
Secondary Outcome Measures
Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
The MWT evaluates a person's ability to remain awake under soporific conditions. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary for Participants With NT1
Participants with NT1 will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary for over 2-week periods throughout the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05816382
Brief Title
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Official Title
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 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 is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916).
Detailed Description
The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). This study will look at the safety of TAK-861 along with improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes.
The study will enroll up to 160 patients from controlled studies conducted with TAK-861. Participants will be assigned to one of the treatment groups according to the dose assigned to them in their parent study. Similarly, participants who were previously on a placebo dose will also be assigned to one of the treatment groups randomly. All participants in the study will receive TAK-861.
Participants with NT1 will receive the following dose from the parent study:
TAK-861 Dose 1
TAK-861 Dose 2
TAK-861 Dose 3
TAK-861 Dose 4 Participants with NT2 will receive either TAK-861 Dose 1 or TAK-861 Dose 2 from the parent study.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 108 weeks. Participants will make multiple visits to the clinic (with some visits optionally conducted by home health), and will have a follow up assessment 4 weeks after last dose of study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy Type 1, Narcolepsy Type 2
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAK-861 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 1 for up to 104 weeks.
Arm Title
TAK-861 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 2 for up to 104 weeks.
Arm Title
TAK-861 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 3 for up to 104 weeks.
Arm Title
TAK-861 Dose 4
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 4 for up to 104 weeks.
Intervention Type
Drug
Intervention Name(s)
TAK-861
Intervention Description
TAK-861 tablets
Primary Outcome Measure Information:
Title
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
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 (e.g., 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 defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame
From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 108 weeks)
Secondary Outcome Measure Information:
Title
Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Description
The MWT evaluates a person's ability to remain awake under soporific conditions. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Time Frame
Baseline (parent study), Week 26 (current long-term extension [LTE] study)
Title
Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score
Description
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
Time Frame
Baseline (parent study); Week 2 through Week 105 (current LTE study)
Title
Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary for Participants With NT1
Description
Participants with NT1 will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary for over 2-week periods throughout the study.
Time Frame
Baseline (parent study); Week 10 through Week 105 (current LTE study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
1. Participant with a diagnosis of narcolepsy who has completed a controlled study with TAK-861 (including participants diagnosed with NT1 or NT2) and for whom the investigator has no clinical objection to their enrollment.
Exclusion criteria:
Participant has a moderate or severe ongoing treatment emergent adverse event (TEAE) related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
Participant has a positive urine screen for drugs of abuse (findings confirmed) and/or positive alcohol test during any visit in their prior TAK-861 study, or during the screening period for participants with a dosing gap.
Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) on any visit in the parent TAK-861 study, or has positive answers on item 4 or 5 on the Screening/Baseline C-SSRS Lifetime (based on the past year) during the screening assessment for participants with a dosing gap.
Participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) at multiple visits in the parent study and the findings are of clinical significance, per investigator or sponsor opinion, or ALT/AST >1.5 times ULN during the screening period for participants with a dosing gap.
Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention).
Participant has epilepsy or history of seizure.
Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage.
Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
Participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment, or basal cell skin cancer.
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
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Center for Sleep Sciences and Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Name
SDS Clinical Trials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Delta Waves LLC - Hunt - PPDS
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Pediatric Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurotrials Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgia Neuro Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocare Inc
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center - Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Carolina Elite
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Individual Site Status
Recruiting
Facility Name
ARSM Research, LLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
CTI Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Name
Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Individual Site Status
Recruiting
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina - PPDS
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Specialty Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Individual Site Status
Recruiting
Facility Name
Woolcock Institute of Medical Research
City
Glebe
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Individual Site Status
Recruiting
Facility Name
Terveystalo Helsinki Sleep Clinic
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00380
Country
Finland
Individual Site Status
Recruiting
Facility Name
Hopital Pierre-Paul Riquet
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Gui De Chauliac
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Grenoble
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de la Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaet Regensburg am Bezirksklinikum
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite - Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinische Forschung Hamburg
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Neurologico Mediterraneo Neuromed
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Bellaria
City
Bellaria
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume-Shi
State/Province
Hukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Howakai Kuwamizu Hospital
City
Kumamoto-Shi
State/Province
Kumamoto
ZIP/Postal Code
862-0954
Country
Japan
Individual Site Status
Recruiting
Facility Name
YOU ARIYOSHI Sleep Clinic
City
Nagasaki-Shi
State/Province
Nagasaki
ZIP/Postal Code
850-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gokeikai Osaka Kaisei Hospital
City
Osaka-Shi
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Koishikawa Tokyo Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
112-0012
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aichi Medical University Hospital
City
Nagakute
ZIP/Postal Code
480-1195
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kempenhaeghe - PPDS
City
Heeze
State/Province
Noord-Brabant
ZIP/Postal Code
5591 VE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Slaap-Waakcentrum SEIN Heemstede
City
Heemstede
State/Province
Noord-Holland
ZIP/Postal Code
2103 SW
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University of Oslo
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Araba Santiago
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General de Castello
City
Castellón De La Plana
State/Province
Castellon
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de La Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Vithas Madrid Arturo Soria
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Klinik Barmelweid AG
City
Barmelweid
State/Province
Aargau (de)
ZIP/Postal Code
5017
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Neurocenter of Southern Switzerland
City
Lugano
State/Province
Ticino (it)
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitaetsspital Bern - Inselspital
City
Bern
ZIP/Postal Code
43017-3521
Country
Switzerland
Individual Site Status
Recruiting
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/5daa86dd644c4a8c?idFilter=%5B%22TAK-861-2003%22%5D
Description
To obtain more information on the study, click here/on this link.
Learn more about this trial
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
We'll reach out to this number within 24 hrs