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

First listed
Oct 4, 2021
Start date
Apr 9, 2025
Status verified
Aug 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 (22)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202-
UC Irvine Medical CenterOrangeCalifornia92868-
University of Miami Miller School of MedicineMiamiFlorida33136
Brett Alonso Cardenas
[email protected]
305-243-3100
Kamil Detyniecki, MD (PRINCIPAL_INVESTIGATOR)
AdventHealth Innovation TowerOrlandoFlorida32804
Holly Skinner, DO (PRINCIPAL_INVESTIGATOR)
Rare Disease ResearchOrlandoFlorida34746-
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
Madeline McGinty-Holmes
[email protected]
502-629-5568
Jaime Shoup, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HospitalDetroitMichigan48202-
Minnesota Epilepsy Group, P.A.RosevilleMinnesota55102
Sarah Ellis, MD
[email protected]
651-377-8319
Stephanie Ahrens, MD (PRINCIPAL_INVESTIGATOR)
Children's NebraskaOmahaNebraska68114
Sookyong Koh, MD, PhD
[email protected]
773-929-4445
Sookyong Koh (PRINCIPAL_INVESTIGATOR)
Tekton ResearchMarlboroNew Jersey07746
Aimee Kinlan
[email protected]
626-218-8294
Amor Mehta, MD (PRINCIPAL_INVESTIGATOR)
NYU Comprehensive Epilepsy Center - BRANY - PPDSNew YorkNew York10016-4852
Dana Price (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
Jessica Lindley
[email protected]
Ravi Singh, MD (PRINCIPAL_INVESTIGATOR)
On-Site Clinical SolutionCharlotteNorth Carolina28211
Ludny Saintil
[email protected]
800-785-3150
Robert Nahouraii (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27705
Muhammad Zafar, MD
[email protected]
Muhammad Zafar, MD (PRINCIPAL_INVESTIGATOR)
PPD Virtual-Science 37, Inc.MorrisvilleNorth Carolina27560
Victoria Taylor
[email protected]
615-707-9148
Antonio Iglesias, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Eric Marsh, MD (PRINCIPAL_INVESTIGATOR)
Children's Health Specialty CenterDallasTexas75235
Charuta Joshi (PRINCIPAL_INVESTIGATOR)
UTHealth HoustonHoustonTexas77030
Antoinette Bernal-Tent
[email protected]
713-500-7105
Mary Koenig, MD (PRINCIPAL_INVESTIGATOR)
Clinical Neurosciences CenterSalt Lake CityUtah84132
Angela Peters, MD (PRINCIPAL_INVESTIGATOR)

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Arkansas Children's Hospital· Little Rock, ARUC Irvine Medical Center· Orange, CAUniversity of Miami Miller School of Medicine· Miami, FLAdventHealth Innovation Tower· Orlando, FLRare Disease Research· Orlando, FLPediatric Neurology and Epilepsy Specialists· Winter Park, FL

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