drugset / Trial / NCT03731715

Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome

NCT03731715

Phase 1 Completed 18 enrolled SK Life Science, Inc.
Non-randomizedParallel-groupOpen-labelBasic science

Summary

This is an open-label, multi-center study of carisbamate in adult and pediatric subjects with LGS, with single- and multiple-dose PK assessments from Days 1 through 73. There will be a Screening Period of up to 28 days and a Treatment Period of 87 days.

Timeline

Start
2019-02-07
Primary completion
2022-05-23
Completion
2022-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Carisbamate Small molecule 30 mg Oral
Subject Carisbamate Small molecule 70 mg Oral
Subject Carisbamate Small molecule 100 mg Oral