Mid-Atlantic Epilepsy and Sleep Center | Bethesda, MD
Status and phase
Conditions
Treatments
About
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
145 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal