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A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
NCT04462770 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04462770
The ClinicalTrials.gov registry entry for NCT04462770 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Epygenix, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04462770 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04462770?
The interventions under investigation include: Placebo (DRUG), Clemizole HCl (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04462770?
This trial is sponsored by Epygenix, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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