An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Epygenix
Study ID
NCT05066217
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Lennox Gastaut Syndrome

Eligibility Criteria

Sex
ALL
Age
2 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Clemizole HCl — DRUG
    Clemizole HCl will be administered as an oral solution.
  • Placebo — DRUG
    Placebo will be administered as an oral solution.

Study Details

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 Dates

Start date
Apr 9, 2025
Status verified
Apr 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2029

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percent Change in CMMS-28 [ Time Frame: From Baseline Period up to 16 weeks ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202-
UC Irvine Medical CenterOrangeCalifornia92868-
UCI Center for Innovative Health TherapiesOrangeCalifornia92868
David King-Stephens, MD
714-456-7720
David King-Stephens (PRINCIPAL_INVESTIGATOR)
Nemours Children's HealthWilmingtonDelaware19803
Cecelia Krienen, MD
[email protected]
Lily Tran, MD (PRINCIPAL_INVESTIGATOR)
Rare Disease ResearchKissimmeeFlorida34746-
University of Miami Miller School of MedicineMiamiFlorida33136
Brett Alonso Cardenas
[email protected]
305-243-3100
Kamil Detyniecki, MD (PRINCIPAL_INVESTIGATOR)
Pediatric Neurology and Epilepsy SpecialistsWinter ParkFlorida32789-
Re:Cognition HealthChicagoIllinois60611
Antonio Iglesias, MD
[email protected]
312-971-3318
Antonio Iglesias, MD (PRINCIPAL_INVESTIGATOR)
Norton Children's Medical CenterLouisvilleKentucky40202-
Henry Ford HospitalDetroitMichigan48202-
Minnesota Epilepsy Group, P.A.RosevilleMinnesota55102-
Children's NebraskaOmahaNebraska68114-
Neurology Center for Epilepsy and SeizuresMarlboroNew Jersey07746
732-433-3431
Tekton ResearchMarlboroNew Jersey07746
Aimee Kinlan
[email protected]
626-218-8294
Amor Mehta, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine/New York Presbyterian HospitalNew YorkNew York10021
Lundy Santil
[email protected]
800-785-3150
Asim Shahid
[email protected]
Asim Shahid, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health STRIVE ResearchCharlotteNorth Carolina28207-
On-Site Clinical SolutionCharlotteNorth Carolina28211-
Duke University Medical CenterDurhamNorth Carolina27705
Muhammad Zafar, MD
[email protected]
Muhammad Zafar, MD (PRINCIPAL_INVESTIGATOR)
PPD Virtual-Science 37, Inc.MorrisvilleNorth Carolina27560-
UTHealth HoustonHoustonTexas77030-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital· Little Rock, ARUC Irvine Medical Center· Orange, CAUCI Center for Innovative Health Therapies· Orange, CANemours Children's Health· Wilmington, DERare Disease Research· Kissimmee, FLUniversity of Miami Miller School of Medicine· Miami, FL

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