NCT03961568

Cenobamate Open-Label Extension Study for YKP3089C025

A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)

Detailed description

52 Week Open-Label Safety Study of cenobamate adjunctive therapy for subjects who complete double-blind study YKP3089C025. Subjects will have a 12 week double-blind conversion phase where subjects who received placebo in the double-blind study will be converted to cenobamate. Subjects who received cenobamate in the double-blind study will continue to receive their daily dose of cenobamate. Subjects switching from placebo to cenobamate will be titrated starting at 12.5 mg and increase their dose over the course of 12 weeks as follows 12.5 mg for 2 weeks, 25 mg for two weeks, 50 mg for two weeks, 100 mg for two weeks, 150 mg for two weeks, and 200 mg for two weeks. All subjects will receive 200 mg for the last two weeks of the conversion phase to preserve the blind. After completing the double-blind conversion phase, subjects will have 40 weeks of open-label, flexibly dosed cenobamate. The dose range is 50 mg - 200 mg. Primary endpoints are all safety measures. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight

Conditions

• Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy

Interventions

Type	Name	Description
DRUG	Cenobamate	active drug

Timeline

• Start date: 2019-08-13
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2019-05-23
• Last updated: 2026-01-07

Locations

45 sites across 7 countries: United States, Bulgaria, Czechia, Hungary, Poland, Slovakia, Ukraine

Regulatory

• FDA-regulated drug study