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EPX-100 (Clemizole Hydrochloride) as Add-on Therapy to Control Convulsive Seizures in Patients With Dravet Syndrome (ARGUS)

Primary Purpose

Dravet Syndrome

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EPX-100 (Clemizole HCl)
Placebo
Sponsored by
Epygenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dravet Syndrome focused on measuring Clemizole Hydrochloride, Convulsive Seizure, Pediatric epilepsy, Dravet

Eligibility Criteria

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

Inclusion Criteria:

  1. Male and female participants 2 years and older at time of consent.
  2. Participant or parent/Legally Authorized Representative (LAR) willing and able to provide written informed consent, assent (if applicable) prior to initiation of any study related procedures.
  3. Clinical diagnosis of Dravet Syndrome. Participants must have seizures which are not completely controlled by AEDs with the following criteria:

    • Onset of seizures prior to 18 months of age,
    • Normal development at onset,
    • History of seizures that are generalized, unilateral clonic, and/or hemiclonic,
    • Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of Dravet Syndrome), and
    • Genetic mutation of the SCN1A gene must be documented.
  4. The participant must be approved to participate by the Independent Reviewer, in collaboration with the PI. Participants will be approved for participation following review of the participant's medical and seizure history, historical neuroimaging, historical EEGs, genetic report confirming SCN1A mutation, and review and classification of at least 28 days of baseline seizures.
  5. ≥4 countable convulsive seizures within minimum 28-day screening/baseline period (e.g., hemiclonic, secondarily generalized tonic-clonic, generalized tonic-clonic, tonic, clonic, tonic/atonic (resulting in a drop), and focal with clear observable motor signs).
  6. Participants should be on a stable regimen of AEDs ≥30 days prior to Visit 1 and generally in good health.
  7. Participant or parent/ LAR is able and willing to maintain an accurate and complete daily seizure and medication diary for the duration of the trial.
  8. Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative serum or urine pregnancy test at the screening (Visit 1) and Randomization (Visit 2). A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). Use of oral contraceptives in combination with another method (e.g., a spermicidal cream) is acceptable. In participants who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of non-child-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women are excluded from this study.

Exclusion Criteria:

The presence of any of the following excludes a participant from study enrollment:

  1. Known sensitivity, allergy, or previous exposure to EPX-100 (clemizole HCl).
  2. Exposure to any investigational drug or device <90 days prior to screening or plans to participate in another drug or device trial at any time during the study.
  3. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system (CNS) disease deemed progressive, metabolic illness, or progressive degenerative disease.
  4. Concurrent use of drugs known to interfere with EPX-100, including moderate or severe inducers or inhibitors of CYP3A4/5/7. Specifically, concurrent use of carbamazepine, oxcarbazepine and/or phenytoin, as well as refraining from grapefruits and grapefruit juice during the study period. Refer to Appendix 1 for a list of prohibited drugs.
  5. Prior or concurrent use of lorcaserin.
  6. Concurrent use of fenfluramine. Participants with prior use of fenfluramine within the previous 3 months, or without proper documentation of an echocardiogram, at minimum 3 months following the last dose of fenfluramine, to ensure that the participant does not meet any criteria for drug-related (fenfluramine) cardiac valvular heart disease and/or drug-related pulmonary arterial hypertension (PAH) as indicated by any of the following:

    • documented mild or greater aortic regurgitation [AR] or moderate or greater mitral regurgitation [MR]
    • significant (greater than mild) tricuspid regurgitation
    • abnormally thickened cardiac valve and/or has restricted motion of the valve leaflets
    • elevated right heart/pulmonary artery pressure >35mmHg
  7. Has any medical condition that, in the PI's judgment, is considered to be clinically significant and could potentially affect participant safety or study outcome, including but not limited to: clinically significant cardiac disease (including angina, congestive heart failure, uncontrolled hypertension, and history of arrhythmias), renal, pulmonary, gastrointestinal, hematologic or hepatic conditions; or a condition that affects the absorption, distribution, metabolism, or excretion of drugs.
  8. Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years.

Sites / Locations

  • Children's Hospital of Los AngelesRecruiting
  • UCSF Medical CenterRecruiting
  • Nemours Children's Hospital-DERecruiting
  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
  • University of Michigan- Mott Children's HospitalRecruiting
  • Northeast Regional Epilepsy Group
  • Wake Forest Baptist Health Sciences Department of NeurologyRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Cleveland Clinic
  • Children's Hospital of PhiladelphiaRecruiting
  • Le Bonheur Children's HospitalRecruiting
  • Child Neurology Consultants of AustinRecruiting
  • University of UtahRecruiting
  • Seattle Children'sRecruiting
  • UBC Children's Hospital Research InstituteRecruiting
  • Children's Hospital of Eastern OntarioRecruiting
  • The Hospital for Sick ChildrenRecruiting
  • Toronto Western Hospital, University Health NetworkRecruiting
  • LEPL Tbilisi State Medical University, Givi Zhvania Academic, Clinic of PediatryRecruiting
  • LTD Medi Club Georgia LLCRecruiting
  • LTD Institute of Neurology and NeuropsychologyRecruiting
  • Semmelweis University First Department of Pediatrics, Division of Child NeurologyRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario Infantil Niño JesúsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active arm with EPX-100 (Clemizole HCl)

Placebo arm

Arm Description

EPX-100 oral solution

Color- and taste-matched placebo oral solution dosed to match the active arm.

Outcomes

Primary Outcome Measures

The mean percent change in countable convulsive seizure frequency (CCSF1) in the Titration and Maintenance (T+M) periods relative to baseline.
The mean percent change in countable convulsive seizure frequency (CCSF1) in the Titration and Maintenance (T+M) periods relative to baseline.

Secondary Outcome Measures

The difference between EPX-100 vs placebo in the number of countable convulsive seizure-free days in the T+M periods relative to baseline.
The difference between EPX-100 vs placebo in the number of countable convulsive seizure-free days in the T+M periods relative to baseline.
The difference between EPX-100 vs placebo in proportion of participants with >50% reduction in the mean CCSF in the T+M periods relative to baseline.
The difference between EPX-100 vs placebo in proportion of participants with >50% reduction in the mean CCSF in the T+M periods relative to baseline.
The total change in Seizure Severity using Hague Seizure Severity Scale (HASS).
The total change in Seizure Severity using Hague Seizure Severity Scale (HASS).
The improvement in Clinical Global Impression (CGI).
The improvement in Clinical Global Impression (CGI).
The total change in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
The total change in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
The difference between EPX-100 vs placebo in proportion of participants with >25% reduction in the mean CCSF in the T+M periods relative to baseline.
The difference between EPX-100 vs placebo in proportion of participants with >25% reduction in the mean CCSF in the T+M periods relative to baseline.
The mean difference between EPX-100 vs placebo per 28-days in the percent change of all seizures in the T+M periods relative to the baseline.
The mean difference between EPX-100 vs placebo per 28-days in the percent change of all seizures in the T+M periods relative to the baseline.
The change in the number of episodes of status epilepticus, in the T+M periods relative to the baseline.
The change in the number of episodes of status epilepticus, in the T+M periods relative to the baseline.
The incidence of rescue anti-epileptic drug (AED) use between EPX-100 and placebo, as measured by the number of days on rescue AEDs in the T+M periods relative to the baseline.
The incidence of rescue anti-epileptic drug (AED) use between EPX-100 and placebo, as measured by the number of days on rescue AEDs in the T+M periods relative to the baseline.
The individual item changes in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
The individual item changes in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
The individual item changes in Seizure Severity using Hague Seizure Severity Scale (HASS).
The individual item changes in Seizure Severity using Hague Seizure Severity Scale (HASS).
The change in the Sleep Disturbance Scale for Children (SDSC) between EPX-100 and placebo by each scheduled visit
The change in the Sleep Disturbance Scale for Children (SDSC) between EPX-100 and placebo by each scheduled visit

Full Information

First Posted
July 6, 2020
Last Updated
June 22, 2023
Sponsor
Epygenix
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1. Study Identification

Unique Protocol Identification Number
NCT04462770
Brief Title
EPX-100 (Clemizole Hydrochloride) as Add-on Therapy to Control Convulsive Seizures in Patients With Dravet Syndrome
Acronym
ARGUS
Official Title
A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

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

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 purpose of this study is to evaluate the safety and efficacy of EPX-100 as adjunctive therapy in children and adult participants with Dravet Syndrome.
Detailed Description
This is a global, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of EPX-100 as adjunctive therapy in children and adult participants with Dravet Syndrome. The study consists of a 4-week observational period, a 16-week double blind period and a 3-year open label extension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dravet Syndrome
Keywords
Clemizole Hydrochloride, Convulsive Seizure, Pediatric epilepsy, Dravet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized 1:1 to EPX-100 or placebo.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Matching active vs placebo solutions have been prepared including color and taste.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active arm with EPX-100 (Clemizole HCl)
Arm Type
Experimental
Arm Description
EPX-100 oral solution
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Color- and taste-matched placebo oral solution dosed to match the active arm.
Intervention Type
Drug
Intervention Name(s)
EPX-100 (Clemizole HCl)
Other Intervention Name(s)
Clemizole Hydrochloride, Clemizole HCl, Clemizole
Intervention Description
Daily dose of EPX100
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo to match EPX-100 solution
Intervention Description
Daily dose of Placebo
Primary Outcome Measure Information:
Title
The mean percent change in countable convulsive seizure frequency (CCSF1) in the Titration and Maintenance (T+M) periods relative to baseline.
Description
The mean percent change in countable convulsive seizure frequency (CCSF1) in the Titration and Maintenance (T+M) periods relative to baseline.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
The difference between EPX-100 vs placebo in the number of countable convulsive seizure-free days in the T+M periods relative to baseline.
Description
The difference between EPX-100 vs placebo in the number of countable convulsive seizure-free days in the T+M periods relative to baseline.
Time Frame
20 weeks
Title
The difference between EPX-100 vs placebo in proportion of participants with >50% reduction in the mean CCSF in the T+M periods relative to baseline.
Description
The difference between EPX-100 vs placebo in proportion of participants with >50% reduction in the mean CCSF in the T+M periods relative to baseline.
Time Frame
20 weeks
Title
The total change in Seizure Severity using Hague Seizure Severity Scale (HASS).
Description
The total change in Seizure Severity using Hague Seizure Severity Scale (HASS).
Time Frame
20 weeks
Title
The improvement in Clinical Global Impression (CGI).
Description
The improvement in Clinical Global Impression (CGI).
Time Frame
20 weeks
Title
The total change in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
Description
The total change in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
Time Frame
20 weeks
Title
The difference between EPX-100 vs placebo in proportion of participants with >25% reduction in the mean CCSF in the T+M periods relative to baseline.
Description
The difference between EPX-100 vs placebo in proportion of participants with >25% reduction in the mean CCSF in the T+M periods relative to baseline.
Time Frame
20 weeks
Title
The mean difference between EPX-100 vs placebo per 28-days in the percent change of all seizures in the T+M periods relative to the baseline.
Description
The mean difference between EPX-100 vs placebo per 28-days in the percent change of all seizures in the T+M periods relative to the baseline.
Time Frame
20 weeks
Title
The change in the number of episodes of status epilepticus, in the T+M periods relative to the baseline.
Description
The change in the number of episodes of status epilepticus, in the T+M periods relative to the baseline.
Time Frame
20 weeks
Title
The incidence of rescue anti-epileptic drug (AED) use between EPX-100 and placebo, as measured by the number of days on rescue AEDs in the T+M periods relative to the baseline.
Description
The incidence of rescue anti-epileptic drug (AED) use between EPX-100 and placebo, as measured by the number of days on rescue AEDs in the T+M periods relative to the baseline.
Time Frame
20 weeks
Title
The individual item changes in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
Description
The individual item changes in Quality of Life in Childhood Epilepsy short form (QOLCE 55).
Time Frame
20 weeks
Title
The individual item changes in Seizure Severity using Hague Seizure Severity Scale (HASS).
Description
The individual item changes in Seizure Severity using Hague Seizure Severity Scale (HASS).
Time Frame
20 weeks
Title
The change in the Sleep Disturbance Scale for Children (SDSC) between EPX-100 and placebo by each scheduled visit
Description
The change in the Sleep Disturbance Scale for Children (SDSC) between EPX-100 and placebo by each scheduled visit
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants 2 years and older at time of consent. Participant or parent/Legally Authorized Representative (LAR) willing and able to provide written informed consent, assent (if applicable) prior to initiation of any study related procedures. Clinical diagnosis of Dravet Syndrome. Participants must have seizures which are not completely controlled by AEDs with the following criteria: Onset of seizures prior to 18 months of age, Normal development at onset, History of seizures that are generalized, unilateral clonic, and/or hemiclonic, Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of Dravet Syndrome), and Genetic mutation of the SCN1A gene must be documented. The participant must be approved to participate by the Independent Reviewer, in collaboration with the PI. Participants will be approved for participation following review of the participant's medical and seizure history, historical neuroimaging, historical EEGs, genetic report confirming SCN1A mutation, and review and classification of at least 28 days of baseline seizures. ≥4 countable convulsive seizures within minimum 28-day screening/baseline period (e.g., hemiclonic, secondarily generalized tonic-clonic, generalized tonic-clonic, tonic, clonic, tonic/atonic (resulting in a drop), and focal with clear observable motor signs). Participants should be on a stable regimen of AEDs ≥30 days prior to Visit 1 and generally in good health. Participant or parent/ LAR is able and willing to maintain an accurate and complete daily seizure and medication diary for the duration of the trial. Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative serum or urine pregnancy test at the screening (Visit 1) and Randomization (Visit 2). A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). Use of oral contraceptives in combination with another method (e.g., a spermicidal cream) is acceptable. In participants who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of non-child-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women are excluded from this study. Exclusion Criteria: The presence of any of the following excludes a participant from study enrollment: Known sensitivity, allergy, or previous exposure to EPX-100 (clemizole HCl). Exposure to any investigational drug or device <90 days prior to screening or plans to participate in another drug or device trial at any time during the study. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system (CNS) disease deemed progressive, metabolic illness, or progressive degenerative disease. Concurrent use of drugs known to interfere with EPX-100, including moderate or severe inducers or inhibitors of CYP3A4/5/7. Specifically, concurrent use of carbamazepine, oxcarbazepine and/or phenytoin, as well as refraining from grapefruits and grapefruit juice during the study period. Refer to Appendix 1 for a list of prohibited drugs. Prior or concurrent use of lorcaserin. Concurrent use of fenfluramine. Participants with prior use of fenfluramine within the previous 3 months, or without proper documentation of an echocardiogram, at minimum 3 months following the last dose of fenfluramine, to ensure that the participant does not meet any criteria for drug-related (fenfluramine) cardiac valvular heart disease and/or drug-related pulmonary arterial hypertension (PAH) as indicated by any of the following: documented mild or greater aortic regurgitation [AR] or moderate or greater mitral regurgitation [MR] significant (greater than mild) tricuspid regurgitation abnormally thickened cardiac valve and/or has restricted motion of the valve leaflets elevated right heart/pulmonary artery pressure >35mmHg Has any medical condition that, in the PI's judgment, is considered to be clinically significant and could potentially affect participant safety or study outcome, including but not limited to: clinically significant cardiac disease (including angina, congestive heart failure, uncontrolled hypertension, and history of arrhythmias), renal, pulmonary, gastrointestinal, hematologic or hepatic conditions; or a condition that affects the absorption, distribution, metabolism, or excretion of drugs. Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorianne Masuoka, M.D.
Phone
(415) 933-0826
Email
lm@epygenix.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rebekah DeVitry Fries
Email
rfries@epygenix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorianne Masouka, MD
Organizational Affiliation
Epygenix Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Arellano-Garcia
Phone
323-361-5812
Email
margarcia@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Deborah L Holder, MD
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Pfeifer
Phone
415-353-8440
Email
kristina.pfeifer@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Ernesto Gonzalez-Giraldo, MD
Facility Name
Nemours Children's Hospital-DE
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Klipner, RN
Phone
302-344-1528
Email
kklipner@nemours.org
First Name & Middle Initial & Last Name & Degree
Stephen Falchek, MD
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Stosic, MD
Phone
312-227-4525
Email
mstosic@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Linda C Laux, MD
Facility Name
University of Michigan- Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Nordhaus
Phone
734-936-4179
Email
nbrittan@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Julie Ziobro, MD, PhD
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Terminated
Facility Name
Wake Forest Baptist Health Sciences Department of Neurology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Hedrick
Phone
336-716-8694
Email
cwhedric@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Gautam Popli, Professor
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Ballard, BSN, RN, CPN
Phone
513-803-3177
Email
samantha.ballard@cchmc.org
First Name & Middle Initial & Last Name & Degree
Gewalin Aungaroon, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honglian Huang, PhD
Phone
216-445-2366
Email
huangh2@ccf.org
First Name & Middle Initial & Last Name & Degree
Elia Margarita Pestana Knight, MD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennie Minnick
Phone
215-419-3212
Email
minnick@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Eric Marsh, MD, PhD
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenishia Guy
Phone
901-287-7484
Email
Kenishia.Guy@lebonheur.org
First Name & Middle Initial & Last Name & Degree
James Wheless, MD
Facility Name
Child Neurology Consultants of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Henderson
Phone
210-416-4163
Email
Victoria.Henderson@mednax.com
First Name & Middle Initial & Last Name & Degree
Karen Keough, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Beeler
Phone
801-585-9266
Email
laura.beeler@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Angela Peters, MD
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Guidry
Phone
206-987-0058
Email
laurie.guidry@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Russell P Saneto, DO, PhD
Facility Name
UBC Children's Hospital Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inderpal Gill
Phone
604-875-2345
Ext
6834
Email
inderpal.gill@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Mary Connolly, MD
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Healy
Phone
613-738-4297
Email
shealy@cheo.on.ca
First Name & Middle Initial & Last Name & Degree
Sharon Whiting, MD
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura MacDougall, PhD, CCRP
Phone
416-813-7996
Email
laura.macdougall@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Christine Kowal
Phone
416-813-7653
Email
christine.kowal@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Elizabeth Donner, MD
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Selvadurai, MD
Phone
(416) 603-5800
Ext
5906
Email
sarah.selvadurai2@uhn.ca
First Name & Middle Initial & Last Name & Degree
Danielle M Andrade, MD
Facility Name
LEPL Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tinatin Nadiradze
Phone
00995592552929
Email
t.nadiradze@tsmu.edu
First Name & Middle Initial & Last Name & Degree
Sophia Bakhtadze, MD
Facility Name
LTD Medi Club Georgia LLC
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Gachechiladze
Phone
00995598357909
Email
tamogachechiladze@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gia Melikishvili, MD
Facility Name
LTD Institute of Neurology and Neuropsychology
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sopiko Digmelashvili
Phone
00995551516066
Email
sopikodigmelashvili@gmail.com
First Name & Middle Initial & Last Name & Degree
David Kvernadze, MD
Facility Name
Semmelweis University First Department of Pediatrics, Division of Child Neurology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrásné Koród
Phone
0036 06 20 825 8208
Email
korodi.kata@@gmail.com
First Name & Middle Initial & Last Name & Degree
Victor Farkas, MD
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roser Ribosa
Phone
+ 34618846 138
Email
RRibosa@santpau.cat
First Name & Middle Initial & Last Name & Degree
Susana Boronat, MD
Facility Name
Hospital Universitario Infantil Niño Jesús
City
Madrid
State/Province
Madrid Provincia
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Ventosino
Phone
+34 616 531 224
Ext
7351
Email
nuria.ventosino@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Victor Soto, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

EPX-100 (Clemizole Hydrochloride) as Add-on Therapy to Control Convulsive Seizures in Patients With Dravet Syndrome

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