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NCT04462770 · ClinicalTrials.gov registry record · Phase 3
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
A Phase 3 study of Dravet Syndrome, sponsored by Epygenix.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT04462770: Recruiting Phase 3 study of Dravet Syndrome, sponsored by Epygenix.
NCT04462770 is a Phase 3 study of Dravet Syndrome that is actively recruiting participants, run by Epygenix. The registered enrollment target is 150 participants, above the 97-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04462770, a Phase 3 study of Dravet Syndrome, is actively recruiting participants, sponsored by Epygenix.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).
Primary Outcome
Percent change in CMS-28 from the Baseline Period through the end of the DB period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Clemizole HCl
Study Locations (20)
California
- Children's Hospital of Los Angeles - Los Angeles
- University of California Irvine - Orange
- UCSF Medical Center - San Francisco
Florida
- Rare Disease Research FL - Kissimmee
- Pediatric Neurology and Epilepsy Specialists - Winter Park
New Jersey
- Northeast Regional Epilepsy Group - Hackensack
- Neurology Center for Epilepsy and Seizures - Marlboro
New York
- Weill Cornell Medical Center - New York
- Northwell Health - Lenox Hill Hospital - New York
North Carolina
- Duke University Health System - Durham
- Wake Forest Baptist Medical Center - Winston-Salem
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
Connecticut
- Yale University School of Medicine - New Haven
Delaware
- The Nemours Foundation - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2029-05-01 |
| Phase | Phase 3 |
What NCT04462770 shows while recruiting
NCT04462770 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Dravet Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04462770 names 20 study sites across 13 states, led by California, Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04462770 about?
NCT04462770 is a clinical study titled "A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome". This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).
What is the current status of trial NCT04462770?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2020-09-15. Estimated completion is 2029-05-01.
What conditions does trial NCT04462770 study?
This clinical trial studies the following conditions: Dravet Syndrome.
What interventions are being tested in trial NCT04462770?
The interventions under investigation include: Placebo (DRUG), Clemizole HCl (DRUG).
Who is sponsoring clinical trial NCT04462770?
This trial is sponsored by Epygenix, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04462770 being conducted?
This trial has 20 study locations across California, Connecticut, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dravet Syndrome
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Where NCT04462770's enrollment target sits among peer trials
150 5th of 12 higher than 8 of 12 other Dravet Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dravet Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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