Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
NCT ID: NCT04062981
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2019-05-03
2022-12-14
Brief Summary
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Detailed Description
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This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cohort I
Subjects ≥ 18 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
Carisbamate
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
Cohort II
Subjects 12 to \<18 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
Carisbamate
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
Cohort III
Subjects 6 to \<12 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
Carisbamate
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
Cohort IV
Subjects 2 to \<6 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
Carisbamate
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
Interventions
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Carisbamate
An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Investigator believes subject could benefit from continued exposure to study drug
2 Years
ALL
No
Sponsors
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SK Life Science, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Kamin, MD
Role: STUDY_DIRECTOR
SK Life Science, Inc.
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Oregon Health and Science University
Portland, Oregon, United States
The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)
Salt Lake City, Utah, United States
UW Valley Medical Center
Renton, Washington, United States
Countries
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Other Identifiers
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YKP509C002
Identifier Type: -
Identifier Source: org_study_id
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