A study to evaluate the effectiveness and safety of study drug (sepranolone) in women with menstrual migraine

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 84

Inclusion Criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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:
8.suffering any other medically significant and unstable disease potentially interfering with or being negatively affected by participation in the study, as judged by the investigator.
9.pregnant or breast-feeding, or planning pregnancy during the study period
10.taking any systemic steroid hormonal treatment (including hormonal IUD) during 3 months before the study visit. Topical corticosteroids and stable doses of inhalational treatment for asthma or seasonal allergy may be allowed. For injectable hormonal contraceptives, a 6-month washout is required.
11.previously been diagnosed with a major psychiatric disorder according to DSM 5® criteria, including drug abuse or dependency
12.taking disallowed medications or allowed with restrictions with respect to their use prior to or during the study (this list is not comprehensive). Disallowed medications include: corticosteroids, OCTs, over-the-counter or prescription drugs for PMS symptoms, including but not limited to, bioidentical hormones, St John’s wort, Evening primrose oil, Agnus castor.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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