Primary Outcome Measures:
- Change in weekly seizure frequency (including POS with or without secondary generalization, but not non-motor SPS)at study end compared to baseline at beginning of the double-blind study (1042-0600) [ Time Frame: 26-32 weeks ]
Secondary Outcome Measures:
- Responder rate. Responder is defined as patients experiencing ≥50% of reduction in weekly seizure frequency at study end from the baseline [ Time Frame: 26-32 weeks ]
- Number of seizure-free subjects and seizure-free rate [ Time Frame: 26-32 weeks ]
- The weekly seizure frequencies for each seizure subtype: POS with or without secondary generalization, but not non-motor SPS [ Time Frame: 26-32 weeks ]
- Seizure severity and quality of life surveys [ Time Frame: 26 weeks ]
- Change in rate of seizures in catamenial epilepsy [ Time Frame: 26-32 weeks ]
This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults with partial onset epilepsy with or without secondary generalizations.
The study consists of 13 visits over 108 (+or-2) weeks.