Primary Treatment: CVL-865 · Has Placebo Group · Phase 2
High Dose: CVL-865 25 mg
Drug
Experimental Group · 1 Intervention: CVL-865 · Intervention Types: Drug
Low Dose: CVL-865 7.5 mg
Drug
Experimental Group · 1 Intervention: CVL-865 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 15, day 43, day 71, day 92 and/or early termination (et)
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
26 Previous Clinical Trials
4,290 Total Patients Enrolled
1 Trials studying Seizures
120 Patients Enrolled for Seizures
Ann Dandurand, MDStudy DirectorCerevel Therapeutics, LLC
4 Previous Clinical Trials
319 Total Patients Enrolled
1 Trials studying Seizures
120 Patients Enrolled for Seizures
Eligibility Criteria
Age 18 - 75 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:
You have focal aware, focal impaired awareness, or focal to bilateral tonic-clonic seizures during the 8 week baseline period with no 21-day period free of any of these seizure types.
Participants must have had magnetic resonance imaging or contrast enhanced computed tomography scan of the brain that demonstrated no progressive structural central nervous system abnormality at the time of the diagnosis of epilepsy.
Male must agree to use condom during treatment and until the end of relevant systemic exposure in the male participant for 94 days following the last dose with IMP.
You are taking 1 to 3 permitted AEDs at a stable dose for 4 weeks prior to the Screening Visit.
You must have a body mass index (BMI) of 17.5 to 40.
You are a woman of childbearing potential who agrees to use an effective method of contraception from signing of informed consent throughout the duration of the study and for 30 days post last dose.