Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
SK Life Science, Inc.
Study ID
NCT03731715
Phase
PHASE1
Status
Completed

Conditions

  • Lennox Gastaut Syndrome

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carisbamate — DRUG
    An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)

Study Details

This is an open-label, multi-center study of carisbamate in adult and pediatric subjects with LGS, with single- and multiple-dose PK assessments from Days 1 through 73. There will be a Screening Period of up to 28 days and a Treatment Period of 87 days.

Key Dates

Start date
Feb 7, 2019
Status verified
May 2023
Primary completion
May 23, 2022
Completion
Jun 29, 2022

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort I
    Subjects ≥18 years of age. Carisbamate, 200 mg, will be administered on Day 1 and 2 of the single-dose period. Carisbamate will be administered at 100 mg twice daily (BID) during the multiple-dose period.
  • Experimental: Cohort II
    Subjects 12 to \<18 years of age. Carisbamate, 140 mg, will be administered on Day 1 and 2 of the single dose period. Carisbamate will be administered at 70 mg twice daily (BID) during the multiple-dose period.
  • Experimental: Cohort III
    Subjects 6 to \<12 years of age. Carisbamate, 60 mg, will be administered on Day 1 and 2 of the single dose period. Carisbamate will be administered at 30 mg twice daily (BID) during the multiple-dose period.
  • Experimental: Cohort IV
    Subjects 2 to \<6 years of age. The starting doses for the single dose and multiple-dose periods will be based on the PK and safety results of the first 3 cohorts.

Primary Outcome Measure

The area under the curve (AUC) of carisbamate after a single and multiple doses of carisbamate. [ Time Frame: Days 1-3, Day 17 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21210-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Duke HealthDurhamNorth Carolina27710-
Oregon Health and Science UniversityPortlandOregon97239-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)Salt Lake CityUtah84113-
UW Valley Medical CenterRentonWashington98055-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MDDartmouth-Hitchcock Medical Center· Lebanon, NHDuke Health· Durham, NCOregon Health and Science University· Portland, ORHospital of the University of Pennsylvania· Philadelphia, PAThe University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)· Salt Lake City, UT

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