An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Condition(s) studied
Investigational drug(s) / intervention(s)
Clemizole HCl: Clemizole HCl will be administered as an oral solution.
Placebo: Placebo will be administered as an oral solution.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Percent Change in CMMS-28 — From Baseline Period up to 16 weeks
Percent change in CMMS-28 from the Baseline Period through the end of the DB Period
Trial sites (71)
| Facility | City | Region | Status |
|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | Active Not Recruiting |
| UC Irvine Medical Center | Orange | California | Active Not Recruiting |
| University of Miami Miller School of Medicine | Miami | Florida | Recruiting |
| AdventHealth Innovation Tower | Orlando | Florida | Recruiting |
| Rare Disease Research | Orlando | Florida | Suspended |
| Pediatric Neurology and Epilepsy Specialists | Winter Park | Florida | Active Not Recruiting |
| Re:Cognition Health | Chicago | Illinois | Recruiting |
| Norton Children's Medical Center | Louisville | Kentucky | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | Active Not Recruiting |
| Minnesota Epilepsy Group, P.A. | Roseville | Minnesota | Recruiting |
| Children's Nebraska | Omaha | Nebraska | Recruiting |
| Tekton Research | Marlboro | New Jersey | Recruiting |
| NYU Comprehensive Epilepsy Center - BRANY - PPDS | New York | New York | Recruiting |
| Weill Cornell Medicine/New York Presbyterian Hospital | New York | New York | Recruiting |
| Atrium Health STRIVE Research | Charlotte | North Carolina | Recruiting |
| On-Site Clinical Solution | Charlotte | North Carolina | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| PPD Virtual-Science 37, Inc. | Morrisville | North Carolina | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | Recruiting |
| Children's Health Specialty Center | Dallas | Texas | Recruiting |
| UTHealth Houston | Houston | Texas | Recruiting |
| Clinical Neurosciences Center | Salt Lake City | Utah | Recruiting |
| Xiangya Hospital Central South University | Changsha | Hunan | Recruiting |
| Children's Hospital of Shanghai | Shanghai | Shanghai Municipality | Recruiting |
| Peking University First Hospital - Changqiao Campus | Beijing | China | Recruiting |
| Peking University First Hospital - Daxing Campus | Beijing | China | Recruiting |
| Beijing Children's Hospital, Capital Medical University - PIN | Beijing | China | Recruiting |
| The First Hospital of Jilin University | Changchun | China | Recruiting |
| Hunan Children's Hospital | Changsha | China | Recruiting |
| West China Second University Hospital, Sichuan University - Huaxi Campus | Chengdu | China | Recruiting |
| Chengdu Women's and Children's Central Hospital | Chengdu | China | Recruiting |
| Children's Hospital of Chongqing Medical University | Chongqing | China | Recruiting |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | China | Recruiting |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | China | Recruiting |
| Qilu Hospital of Shandong University | Jinan | China | Recruiting |
| Jiangxi Provincial Children's Hospital | Nanchang | China | Recruiting |
| Shenzhen Children's Hospital | Shenzhen | China | Recruiting |
| Wuhan Children's Hospital | Wuhan | China | Recruiting |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China | Recruiting |
| Xuzhou Children's Hospital | Xuzhou | China | Recruiting |
+ 31 more sites — see the full list on the official registry below.
More Epygenix trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05066217 on ClinicalTrials.gov ↗ ← All trials in the USA