NCT04062981

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

Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.

Conditions

• Lennox Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	Carisbamate	An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)

Timeline

• Start date: 2019-05-03
• Primary completion: 2022-12-14
• Completion: 2022-12-14
• First posted: 2019-08-20
• Last updated: 2024-04-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study