NCT01299870.
Methods | Phase II, randomised, double‐blind, cross‐over trial. |
Participants | Female participants between the ages of 21 and 45 years with a positive diagnosis of catamenial epilepsy. |
Interventions | Keishibukuryogan versus placebo (added to usual antiepileptic drug treatment) for 12 weeks. Follow‐up: up to 36 weeks. |
Outcomes | Safety (up to 36 weeks). Change in seizure frequency (with a focus on an increase in seizure frequency, up to 36 weeks). Change in progesterone levels (up to 36 weeks). |
Notes | Results "submitted" to ClinicalTrials.gov, but not published online or within any journal article known to us. Awaiting assessment if results can be identified. |