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

• Status: Completed
• Trial end date: 2021-05-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asarina Pharma
• Collaborator: Scandinavian CRO
• Treatments: Pregnanolone

Criteria

Inclusion Criteria:

• have Menstrual Migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) verified in three menstrual cycles

• have a regular menstrual cycle of 24-35 days cycle,

• use double barrier contraception, intrauterine device (IUD), be truly sexually abstinent, or subject or her partner has been surgically sterilized,

Exclusion Criteria:

• More than 10 headache days per month on average during screening phase

• steroid hormonal treatment during previous three months

• ongoing treatment with antiepileptic drugs or benzodiazepines

• significant medical or psychiatric condition

• be pregnant or plan a pregnancy within the study period