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- (YKP3089C049) Open-label Study of Cenobamate Monotherapy in Adult Subjects with Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Clinical Trial
(YKP3089C049) Open-label Study of Cenobamate Monotherapy in Adult Subjects with Newly Diagnosed or Recurrent Partial-Onset Epilepsy
This is an uncontrolled, single-arm, open-label Phase IV study conducted at approximately 40 sites in the US. It will consist of a pretreatment period (up to 21 days), 100 mg/day treatment period (6-week titration phase, 26-week maintenance phase), 200 mg/day treatment period (2-week titration phase, 26-week maintenance phase), 26-week optional extension period and follow-up period (2-4 weeks). The primary objective is to assess the effectiveness of cenobamate monotherapy in adult subjects with newly diagnosed or recurrent partial-onset epilepsy.
Eligibility Criteria
- Inclusion Criteria: Subject must be able to record seizures and report adverse events himself/herself or have a caregiver who can report them Diagnosis of partial-onset seizures Male or Female aged 18 to 74 Subject and caregiver must be able to comply with study requirements Exclusion Criteria: Subjects who have only simple partial-onset seizures without motor signs Subjects who have seizure clusters where individual seizures cannot be counted Subjects who present with or have a history of Lennox-Gastaut syndrome Subjects who have a history of status epilepticus that required hospitalization within 1 year prior to Day 1 of the treatement period
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