Using fremanezumab to prevent menstrual migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the effectiveness of fremanezumab in treating menstrual migraine attacks versus non-menstrual migraine attacks in real-world clinical settings. Participants, premenopausal women aged 18 and older with a diagnosis of chronic or episodic migraine, will maintain a headache diary for at least three months prior to and six months after starting treatment with fremanezumab. The study seeks to determine if menstrually-related migraines respond similarly to this anti-CGRP monoclonal antibody treatment as non-menstrually-related migraines.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Premenopausal women of 18 years of age or older.
* Women with a regular cycle 21-32 days.
* The patient has a diagnosis of chronic or episodic migraine.
* Women suffering from migraine with or without aura according to International Headache Society (IHS) Classification (ICHD-3 code A1.1.2 or A1.2.0.2) for at least one year.
* Women suffering of at least 2 days of menstrually-related migraine per period on average in the last three periods (baseline measurements and inclusion criteria).
* The patient has been maintaining a daily headache diary as part of her routine disease management per her treating physician and has 3 months headache diary data prior to baseline/ treatment initiation. Notes: The patient's headache diary captures information on each headache day, headache duration, headache severity, medication intake, each day of menstrual bleeding, pain intensity of symptoms associated with the menstrual bleeding and symptoms of endometriosis (if present): dysmenorrhoea, dyschezia, dyspareunia, dysuria.
* The patient understands and is willing to keep records in their headache diary for the course of the study.
* Initiation of anti-CGRP mAb (fremanezumab) treatment according to the Summary of Product Characteristics (SmPC) during clinical routine as a treatment of their physician (no study-specific intervention). This means that patients have to fulfil criteria for treatment with anti-CGRP mAbs in Switzerland, i.e. they have at least 8 days of migraine per month in the last three months.
* The patient has signed the informed consent.

Exclusion Criteria:

* Patients with pure menstrual migraine.
* The patient is treated with another anti-CGRP mAb.
* The patient is not treated with fremanezumab according to the SmPC.
* The patient is being treated with another anti-CGRP-based preventive migraine medication within 6 months of enrolment.
* The patient is participating in an interventional clinical trial in EM or CM.
* Change of hormone therapy during study treatment.
* Progestin-only contraception.

Where it's running

• Department of Neurology, Inselspital
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Christoph J Schankin, Prof — Inselspital, Department of Neurology, Bern
• Study coordinator: Christoph J Schankin, Prof
• Email: christoph.schankin@insel.ch
• Phone: 00416322111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.