A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine

Summary

The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle. Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two week preceding the menstruation for three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using an electronic diary using validated scales for assessment of menstual migraine symptoms. Sepranolone is identical to an endogenous steroid.

Timeline

Start

2019-08-27

Primary completion

2021-05-15

Completion

2021-05-15

Drugs

Indications