Stopped: Closed early after CVL-865-SZ-001 (NCT04244175) did not meet its primary objective
The purpose of this study is to assess the long-term safety and tolerability of CVL-865 as adjunctive therapy in participants with focal onset seizures.
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Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Timeframe: From first dose of study drug up to Week 61
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECGs)
Timeframe: Baseline up to Week 57
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Measurements
Timeframe: Baseline up to Week 57
Number of Participants With Clinically Significant Changes From Baseline in Physical and Neurological Examination Results
Timeframe: Baseline up to Week 57
Suicidality Based on the Columbia Suicide-Severity Rating Scale (C-SSRS)
Timeframe: Baseline up to Week 61
Change From End of Treatment in Modified Clinical Institute Withdrawal Assessment - Benzodiazepines (mCIWA-B) Score at the End of Post-treatment Follow-up (Week 61)
Timeframe: Week 57, Week 61