Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

Part of paid clinical trials in Palo Alto, California.

Sponsor
SK Life Science, Inc.
Study ID
NCT05219617
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Lennox Gastaut Syndrome
  • Seizures

Eligibility Criteria

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

Interventions

  • Carisbamate — DRUG
    Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]). Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).

Study Details

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Key Dates

Start date
Apr 28, 2022
Status verified
Jul 2025
Primary completion
Feb 28, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Carisbamate 200 mg BID arm
    Age: 4 to \<12y\* Titration: 2 mg/kg BID Maintenance: 4 mg/kg BID Age: ≥12 y Titration: 100 mg BID Maintenance: 200 mg BID
  • Experimental: Carisbamate 300 mg BID arm
    Age: 4 to \<12y\* Titration: 2.75 mg/kg BID Maintenance: 5.5 mg/kg BID Age: ≥12 y Titration: 150 mg BID Maintenance: 300 mg BID
  • Placebo Comparator: Placebo matched to 200 mg BID arm
    Age: 4 to \<12y\* Titration: Volume equivalent to 2 mg/kg BID Maintenance: Volume equivalent to 4 mg/kg BID Age: ≥12 y Titration: Volume equivalent to 100 mg BID Maintenance: Volume equivalent to 200 mg BID
  • Placebo Comparator: Placebo matched to 300 mg BID arm
    Age: 4 to \<12y\* Titration: Volume equivalent to 2.75 mg/kg BID Maintenance: Volume equivalent to 5.5 mg/kg BID Age: ≥12 y Titration: Volume equivalent to 150 mg BID Maintenance: Volume equivalent to 300 mg BID

Primary Outcome Measure

Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period. [ Time Frame: 3 years ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Stanford University HospitalPalo AltoCalifornia94305
Brenda Porter, MD (PRINCIPAL_INVESTIGATOR)
University of Florida Health Science CenterJacksonvilleFlorida32209-
AdventHealthOrlandoFlorida32803-
Pediatric Epilepsy and Neurology SpecialistsTampaFlorida33609
Jose Ferreira, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33620-
Axcess Medical ResearchWellingtonFlorida33414-
Consultants in Epilepsy and Neurology PLLCBoiseIdaho83702-
Bluegrass Epilepsy Research, LLCLexingtonKentucky40504-
University Medical Center New OrleansNew OrleansLouisiana70112-
Johns Hopkins HospitalBaltimoreMaryland21287
Joon Yi Kang, MD (PRINCIPAL_INVESTIGATOR)
Mid-Atlantic Epilepsy and Sleep CenterBethesdaMaryland20817
Arkady Barber
Pavel Klein, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905-
University of Missouri School of MedicineColumbiaMissouri65211-
Northeast Regional Epilepsy GroupHackensackNew Jersey07601
Eric Segal, MD (PRINCIPAL_INVESTIGATOR)
St. Peters HospitalNew BrunswickNew Jersey08901-
MontefioreThe BronxNew York10467-
Duke University Clinical Research at Pickett RoadDurhamNorth Carolina27713
Muhammad Zafar, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest University - School of MedicineWinston-SalemNorth Carolina27101-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Eric Marsh, MD (PRINCIPAL_INVESTIGATOR)
Austin Epilepsy Care Center - Clinic/Outpatient FacilityAustinTexas78758-
Neurology Consultants of Dallas, PA - HospitalDallasTexas75231-
Virginia Epilepsy and Neurodevelopmental Clinic at WNCWinchesterVirginia22601-

Find similar trials in Palo Alto, CA

By research site
Stanford University Hospital· Palo Alto, CAUniversity of Florida Health Science Center· Jacksonville, FLAdventHealth· Orlando, FLPediatric Epilepsy and Neurology Specialists· Tampa, FLUniversity of South Florida· Tampa, FLAxcess Medical Research· Wellington, FL

Related Studies