A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Dravet Syndrome

In brief

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).

Key facts

Study ID

NCT04462770

Run by

Epygenix

People needed

150

Starts

2020-09-15

Expected to finish

2029-05-01

Last updated by the study team

2026-06-30

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• The Hospital for Sick Children — Toronto, Ontario, Canada (enrolling)
• Semmelweis University — Budapest, Hungary (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Children's Hospital of Eastern Ontario Research Institute Inc. — Ottawa, Ontario, Canada (enrolling)
• Medi Club Georgia LLC — Tbilisi, Georgia (enrolling)
• Institute of Neurology and Neuropsychology LTD — Tbilisi, Georgia (enrolling)
• Child Neurology Consultants of Austin — Austin, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• UBC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (enrolling)
• UCSF Medical Center — San Francisco, California, United States (enrolling)
• Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry — Tbilisi, Georgia (enrolling)
• Norton Children's Research Institute — Louisville, Kentucky, United States (enrolling)
• Yale School of Medicine - Yale-New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Children's Nebraska — Omaha, Nebraska, United States (enrolling)
• University of California Irvine — Orange, California, United States (enrolling)
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Weill Cornell Medical Center — New York, New York, United States (enrolling)
• Rare Disease Research FL — Kissimmee, Florida, United States (enrolling)
• Duke University Health System — Durham, North Carolina, United States (enrolling)
• Pediatric Neurology and Epilepsy Specialists — Winter Park, Florida, United States (enrolling)
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada (enrolling)
• University of Debrecen — Debrecen, Hungary (enrolling)

Full record on ClinicalTrials.gov

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