Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
SK Life Science, Inc.
Study ID
NCT04062981
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

Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).

Key Dates

Start date
May 3, 2019
Status verified
Apr 2024
Primary completion
Dec 14, 2022
Completion
Dec 14, 2022

Study Design

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

Arms

  • Experimental: Cohort I
    Subjects ≥ 18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
  • Experimental: Cohort II
    Subjects 12 to \<18 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
  • Experimental: Cohort III
    Subjects 6 to \<12 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.
  • Experimental: Cohort IV
    Subjects 2 to \<6 years of age These subjects will reach maximum stable dose and continue onto YKP509C002.

Primary Outcome Measure

Concomitant medication [ Time Frame: Up to 20 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21210-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Oregon Health and Science UniversityPortlandOregon97239-
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, NHOregon Health and Science University· Portland, ORThe University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)· Salt Lake City, UTUW Valley Medical Center· Renton, WA

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