A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine
Status:
Completed
Trial end date:
2021-05-15
Target enrollment:
Participant gender:
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.