Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Who is this study for? Patients with Lennox Gastaut Syndrome
What treatments are being studied? Carisbamate
Status: Completed
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Johns Hopkins Hospital
Baltimore
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
Oregon
Oregon Health and Science University
Portland
Utah
The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)
Salt Lake City
Washington
UW Valley Medical Center
Renton
Time Frame
Start Date: 2019-05-03
Completion Date: 2022-12-14
Participants
Target number of participants: 15
Treatments
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.
Authors
Steven Phillips, Richard Morse, Yong Park, Colin Roberts, Ronald Davis, Pavel Klein, Michael Gelfand, Ruben Kuzniecky, Matthew Sweney, David Vossler, Raman Sankar
Related Therapeutic Areas
Sponsors
Leads: SK Life Science, Inc.