Status:
COMPLETED
Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Lennox Gastaut Syndrome
Eligibility:
All Genders
2+ years
Phase:
PHASE1
Brief Summary
Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).
Detailed Description
Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate. This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, ...
Eligibility Criteria
Inclusion
- Subjects who completed the YKP509C001 study
- Investigator believes subject could benefit from continued exposure to study drug
- Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study
Exclusion
- Subjects must continue to not meet any of the exclusion criteria from the YKP509C001 study
- There are no additional exclusion criteria in this study
Key Trial Info
Start Date :
May 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04062981
Start Date
May 3 2019
End Date
December 14 2022
Last Update
April 4 2024
Active Locations (5)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21210
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
Oregon Health and Science University
Portland, Oregon, United States, 97239
4
The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)
Salt Lake City, Utah, United States, 84113