Sperling 2017.

Methods	Phase II, 18‐week, double‐blind, placebo‐controlled, randomised clinical trial of ganaxolone administered as add‐on therapy in adults with uncontrolled focal onset seizures.
Participants	Men or women aged 18 to 69 years inclusive were eligible if they had a diagnosis of epilepsy with focal onset seizures with or without secondarily generalised seizures. 100 out of 147 recruited participants were female, and "the female predominance was likely due to the perceived benefit for women who have catamenial epilepsy based on the ganaxolone’s mechanism of action".
Interventions	Ganaxolone (titrated up to 1500 mg/day) or placebo was added to existing antiepileptic drug therapy of up to 3 antiepileptic drugs, which were maintained at a stable dose for at least 30 days prior to enrolment.
Outcomes	Primary outcome: Change in mean weekly seizure frequency for all seizure types including complex focal onset seizures, simple focal onset seizures with motor manifestations, and secondarily generalised seizures (but excluding non‐motor simple partial seizures) during the titration plus maintenance periods (weeks 1 to 10). Secondary outcomes: Change in mean weekly seizure frequency during the maintenance period. Change and per cent change from baseline of mean weekly seizure frequency during the maintenance period and titration plus maintenance period. Weekly seizure frequency for each week after dosing (titration plus maintenance period). Mean weekly seizure frequency and change and per cent change from baseline during the titration plus maintenance period for each seizure subtype (complex partial seizure, generalised tonic–clonic seizure, and simple partial seizure‐motor). Responder rate (≥ 50% reduction from baseline in mean weekly seizure frequency during the titration plus maintenance period from baseline). Number of seizure‐free days during the titration, maintenance, and titration plus maintenance periods. Number of seizure‐free participants and seizure‐free rate during the titration, maintenance, and titration plus maintenance periods. Exploratory endpoints: the Seizure Severity Questionnaire and Quality Of Life In Epilepsy‐31 Inventory (QOLIE‐31)
Notes	Results were not presented separately for participants with catamenial epilepsy. We have contacted the original authors to request results for the subgroup of participants with catamenial epilepsy.