drugset / Trial / NCT05219617
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).
Timeline
- Start
- 2022-04-28
- Primary completion
- 2027-02
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carisbamate | Small molecule | 4 mg/kg | — |
| Subject | Carisbamate | Small molecule | 5.5 mg/kg | — |
| Subject | Carisbamate | Small molecule | 200 mg | — |
| Subject | Carisbamate | Small molecule | 300 mg | — |