An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Lennox Gastaut Syndrome
In brief
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).
Key facts
- Study ID
- NCT05066217
- Run by
- Epygenix
- People needed
- 260
- Starts
- 2025-04-09
- Expected to finish
- 2029-11-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 2 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Neurosphera — Warsaw, Masovian Voivodeship, Poland (enrolling)
- UCI Center for Innovative Health Therapies — Orange, California, United States (enrolling)
- University of Miami Miller School of Medicine — Miami, Florida, United States (enrolling)
- AdventHealth Innovation Tower — Orlando, Florida, United States (enrolling)
- Re:Cognition Health — Chicago, Illinois, United States (enrolling)
- Neurology Center for Epilepsy and Seizures — Marlboro, New Jersey, United States (enrolling)
- Tekton Research — Marlboro, New Jersey, United States (enrolling)
- NYU Comprehensive Epilepsy Center - BRANY - PPDS — New York, New York, United States (enrolling)
- Weill Cornell Medicine/New York Presbyterian Hospital — New York, New York, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Clinical Neurosciences Center — Salt Lake City, Utah, United States (enrolling)
- IRCCS Istituto Neurologico Mediterraneo Neuromed — Pozzilli, Molise, Italy (enrolling)
- On-Site Clinical Solution — Charlotte, North Carolina, United States
- UC Irvine Medical Center — Orange, California, United States
- UTHealth Houston — Houston, Texas, United States
- Nemours Children's Health — Wilmington, Delaware, United States
- Rare Disease Research — Kissimmee, Florida, United States
- PPD Virtual-Science 37, Inc. — Morrisville, North Carolina, United States
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Pediatric Neurology and Epilepsy Specialists — Winter Park, Florida, United States
- Atrium Health STRIVE Research — Charlotte, North Carolina, United States
- Norton Children's Medical Center — Louisville, Kentucky, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Minnesota Epilepsy Group, P.A. — Roseville, Minnesota, United States
Full record on ClinicalTrials.gov
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