Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
Purpose of the Study: The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).
Description: This is a 2-cohort study consisting of 2 phases in each cohort. Phase 1 is a double-blind phase followed by phase 2, an open-label phase. Cohort 1 will provide tolerability, safety and PK information for ganaxolone 1200mg/d, 1800mg/d and placebo. Cohort 2 will investigate the efficacy, tolerability and safety of ganaxolone 1800mg/d compared to placebo. Cohort 1 (N= approximately 50) will enroll into a 67-week study consisting of a 4-week prospective baseline period plus 4 week retrospective baseline followed by two treatment phases: a 9-week randomized DB placebo-controlled treatment phase followed by a 52-week open-label (OL) treatment phase. Cohort 2 (N=150) will enroll into a 72-week study consisting of a 4-week prospective baseline period plus 4-week retrospective baseline followed by two treatment phases: a 14-week randomized DB placebo-controlled treatment phase followed by a 52-week open-label (OL) treatment phase.
Eligibility Criteria: Men and women 18 years and older with drug-resistant epilepsy with partial-onset seizures (POS), with or without secondary generalization, for two or more years, despite having been treated in the past with at least 2 approved anti-epilepsy drugs (AEDs), either alone or in combination. Participants with previous exposure or a known sensitivity to ganaxolone will be excluded.
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