An exploratory phase II, randomised, double-blind, placebo-controlled, parallel-group study investigating the efficacy and safety of Sepranolone in women with menstrual migraine

Asarina Pharma ApS0 sites84 target enrollmentMay 27, 2019

Overview

No summary available.

Registry

who.int

Start Date

May 27, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Main Inclusion Criteria
•The woman must:
•1\.provide her informed consent prior to any study related procedures
•2\.be aged \=18 and \=45 years.
•3\.have a regular menstrual cycle of 24\-35 days
•4\.use sufficient barrier contraception, non\-hormonal IUD, be truly abstinent or the woman or her male sexual partner has been surgically sterilized (further described in Section 4\.3\.1\).
•5\.have a history of migraine according to the IHS classification ICHD\-3 with a history of at least 12 months with migraine in conjunction with menstruation and in at least 2 out of 3 ovulatory menstrual cycles.
•6\.for randomisation, have documented menstrual migraine attacks during at least two menstrual cycles out of the three\-cycle screening and baseline period. A menstrual migraine attack is defined as starting at a time between Day \-2 and Day \+3 of full menstrual flow (limits inclusionary)
•Further, the woman may
•7\.have a total of maximum ten (10\) migraine or other headache days per month.

•Main Exclusion Criteria
•The woman must not have:
•1\.participated in a clinical study and received active drug in such a study within 30 days or 5 study drug half\-lives, whichever the longest, prior to the first study visit.
•2\.in the investigator's opinion, evidence and/or history of any clinically significant neurological disease, other intracranial or systemic diseases or conditions potentially interfering with study assessments
•3\.a BMI \>35 kg/m2\.
•4\.or has had a malignant disease within the previous 5 years (except non\-melanoma skin cancer, cervical or breast ductal carcinoma in situ)
•5\.HIV or ongoing hepatitis by history
•6\.have allergies to ingoing study drug components or a history of anaphylactic reactions.
•7\.have a less than 80% compliance with eDiary reporting during Days \-7 until \+ 7 in each of the three\-cycle baseline periods.
•The woman must not be: