Actively Recruiting
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Led by Epygenix · Updated on 2026-04-15
260
Participants Needed
20
Research Sites
238 weeks
Total Duration
On this page
Sponsors
E
Epygenix
Lead Sponsor
H
Harmony Biosciences Management, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 2 to 55 years at the time of screening
- Participant or legal representative able and willing to provide written informed consent or assent
- Diagnosis of Lennox-Gastaut Syndrome with at least one type of countable major motor seizure
- History of EEG consistent with Lennox-Gastaut Syndrome, including abnormal background activity and either slow spike-wave discharges (<2.5 Hz) or paroxysmal fast activity during sleep
- Abnormal cognitive development
- Onset of seizures at 11 years of age or younger
You will not qualify if you...
- Known allergy, sensitivity, or previous exposure to clemizole HCl
- History of long QT syndrome or significant abnormality in electrocardiogram such as recent myocardial infarction or serious arrhythmia
- Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia linked to QT prolongation
- Seizures caused by illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, progressive CNS disease, metabolic illness, recent anoxic episode requiring resuscitation in last 6 months, or any condition that may affect seizure control
- Planned epilepsy surgery during the study or epilepsy surgery within 6 months prior to screening
- Use of fenfluramine concurrently
- Prior or concurrent use of lorcaserin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Active, Not Recruiting
2
UC Irvine Medical Center
Orange, California, United States, 92868
Active, Not Recruiting
3
UCI Center for Innovative Health Therapies
Orange, California, United States, 92868
Actively Recruiting
4
Nemours Children's Health
Wilmington, Delaware, United States, 19803
Not Yet Recruiting
5
Rare Disease Research
Kissimmee, Florida, United States, 34746
Suspended
6
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
7
Pediatric Neurology and Epilepsy Specialists
Winter Park, Florida, United States, 32789
Active, Not Recruiting
8
Re:Cognition Health
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Norton Children's Medical Center
Louisville, Kentucky, United States, 40202
Active, Not Recruiting
10
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Active, Not Recruiting
11
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, United States, 55102
Active, Not Recruiting
12
Children's Nebraska
Omaha, Nebraska, United States, 68114
Active, Not Recruiting
13
Neurology Center for Epilepsy and Seizures
Marlboro, New Jersey, United States, 07746
Actively Recruiting
14
Tekton Research
Marlboro, New Jersey, United States, 07746
Actively Recruiting
15
Weill Cornell Medicine/New York Presbyterian Hospital
New York, New York, United States, 10021
Actively Recruiting
16
Atrium Health STRIVE Research
Charlotte, North Carolina, United States, 28207
Active, Not Recruiting
17
On-Site Clinical Solution
Charlotte, North Carolina, United States, 28211
Active, Not Recruiting
18
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
19
PPD Virtual-Science 37, Inc.
Morrisville, North Carolina, United States, 27560
Active, Not Recruiting
20
UTHealth Houston
Houston, Texas, United States, 77030
Active, Not Recruiting
Research Team
J
Juby Philip
CONTACT
C
Cindy Sandy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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