Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

Summary

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).

Timeline

Start

2013-10

Primary completion

2016-05

Completion

2016-10

Outcome

Missed primary endpoint

registry analysis (other test); Double Blind: Cohort 2: Ganaxolone vs Double Blind: Cohort 2: Placebo; p = 0.1788; Median Difference (Final Values) -7.06 (95% CI -17.44 to 3.52) NCT01963208 ↗

Drugs

Indications