Actively Recruiting
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
Led by Epygenix · Updated on 2026-04-15
260
Participants Needed
20
Research Sites
156 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
Researchers are evaluating the efficacy and safety of clemizole HCl as an additional treatment for children and adults aged 2 to 55 years with Lennox-Gastaut syndrome (LGS), a complex form of epilepsy. This multicenter, Phase 3, randomized, double-blind, placebo-controlled trial is designed to assess how well clemizole HCl works alongside other treatments in controlling seizures associated with LGS. Participants will be randomly assigned to receive either clemizole HCl or a placebo, both given as oral solutions, during the double-blind period. After completing this phase, eligible participants may choose to join an optional open-label extension where they will receive clemizole HCl for up to three years. The study includes an initial observational period, the double-blind treatment period, and the long-term extension phase. During the trial, participants will undergo various assessments including seizure counts, electroencephalogram (EEG) evaluations, and quality of life questionnaires. Researchers will track changes in seizure frequency and intensity, as well as global impressions of change by clinicians and caregivers. Safety will be monitored throughout the study, which may last up to approximately 172 weeks. Participants will be regularly evaluated for treatment effects and adverse events to understand the impact of clemizole HCl on LGS.
CONDITIONS
Brief 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 screening
- Willing and able to provide written informed consent or assent
- Diagnosis of Lennox-Gastaut syndrome confirmed by:
- At least one type of countable major motor seizure
- EEG showing abnormal background activity and either slow spike-wave discharges (<2.5 Hz) or paroxysmal fast activity during sleep
- Abnormal cognitive development
- Seizure onset at 11 years of age or younger
You will not qualify if you...
- Known allergy or prior exposure to clemizole HCl
- History of long QT syndrome or serious ECG abnormalities such as recent myocardial infarction or significant arrhythmia
- Family history of sudden cardiac death or unexplained death related to QT prolongation
- Seizures caused by illicit drug or alcohol use, infection, tumor, demyelinating or degenerative neurological disease, metabolic illness, recent anoxic episode requiring resuscitation, or other progressive conditions affecting seizure control
- Planned epilepsy surgery during the study or surgery within 6 months before screening
- Current use of fenfluramine
- Prior or current use of lorcaserin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants are observed to establish baseline seizure activity before starting treatment.
Visits according to study schedule prior to randomization
Duration - Up to 16 weeks
Participants receive clemizole HCl or placebo as adjunctive therapy to manage Lennox-Gastaut syndrome.
Multiple visits during treatment period per study schedule
Duration - Up to 3 years
Eligible participants who complete the double-blind treatment may continue receiving clemizole HCl for extended evaluation of long-term safety and efficacy.
Visits throughout extension period per study schedule
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
C
Cindy Sandy
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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