Find Lennox-Gastaut Syndrome (LGS) Clinical Trials Near You
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
Who is this study for? Children with Lennox-Gastaut syndrome
What treatments are being studied? Clemizole HCl
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 55
Healthy Volunteers: f
View:
• Males or females, ages ≥2 to ≤55 years, at the time of Screening.
• Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
• Diagnosis of LGS, including:
‣ Evidence of at least one type of countable major motor seizure.
⁃ History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\<2.5 Hz\], or 2) paroxysmal fast activity during sleep).
⁃ Abnormal cognitive development.
⁃ Onset of seizures at 11 years of age or younger.
Locations
United States
Arkansas
Arkansas Children's Hospital
ACTIVE_NOT_RECRUITING
Little Rock
California
UC Irvine Medical Center
ACTIVE_NOT_RECRUITING
Orange
UCI Center for Innovative Health Therapies
RECRUITING
Orange
Delaware
Nemours Children's Health
NOT_YET_RECRUITING
Wilmington
Florida
Rare Disease Research
SUSPENDED
Kissimmee
University of Miami Miller School of Medicine
RECRUITING
Miami
Pediatric Neurology and Epilepsy Specialists
ACTIVE_NOT_RECRUITING
Winter Park
Illinois
Re:Cognition Health
RECRUITING
Chicago
Kentucky
Norton Children's Medical Center
ACTIVE_NOT_RECRUITING
Louisville
Michigan
Henry Ford Hospital
ACTIVE_NOT_RECRUITING
Detroit
Minnesota
Minnesota Epilepsy Group, P.A.
ACTIVE_NOT_RECRUITING
Roseville
North Carolina
Atrium Health STRIVE Research
ACTIVE_NOT_RECRUITING
Charlotte
On-Site Clinical Solution
ACTIVE_NOT_RECRUITING
Charlotte
Duke University Medical Center
RECRUITING
Durham
PPD Virtual-Science 37, Inc.
ACTIVE_NOT_RECRUITING
Morrisville
Nebraska
Children's Nebraska
ACTIVE_NOT_RECRUITING
Omaha
New Jersey
Neurology Center for Epilepsy and Seizures
RECRUITING
Marlboro
Tekton Research
RECRUITING
Marlboro
New York
Weill Cornell Medicine/New York Presbyterian Hospital
RECRUITING
New York
Texas
UTHealth Houston
ACTIVE_NOT_RECRUITING
Houston
Contact Information
Primary
Juby Philip
clinicaltrials@harmonybiosciences.com
(302) 559-4320
Backup
Cindy Sandy
clinicaltrials@harmonybiosciences.com
(317) 258-7262
Time Frame
Start Date:2025-04-09
Estimated Completion Date:2029-11-01
Participants
Target number of participants:260
Treatments
Placebo_comparator: Placebo
Participants will receive their first dose of study drug following randomization.
Experimental: Double-blind clemizole HCl
Participants will receive their first dose of study drug following randomization.
Experimental: Open-label clemizole HCl
Eligible participants who complete the DB Period will have the option to continue in the OLE Period, during which they will receive clemizole HCl for up to 3 years.