Cenobamate Open-Label Extension Study for YKP3089C025

Conditions

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

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cenobamate — DRUG
  active drug

Study Details

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

Key Dates

Start date

Aug 13, 2019

Status verified

Jan 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

145 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Core Study Placebo
  Subjects who did not receive Cenobamate in the Core Study will receive Cenobamate 12.5 mg tablet once a day for two weeks, 25 mg tablet once a day for two weeks, 50 mg tablet once a day for two weeks, 100 mg tablets once a day for two weeks, 150 mg tablets once a day for two weeks and 200 mg tablets once a day for twelve weeks. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.
• Experimental: Core Study Active
  Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg). Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.

Primary Outcome Measure

Incidence of Adverse Events and SAEs [ Time Frame: 386 +/- 2 days ]

Locations (16)

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