Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

Last updated: October 23, 2024
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

Migraine And Cluster Headaches

Migraine (Adult)

Menstrual Disorders

Treatment

Fremanezumab

Clinical Study ID

NCT06659120
2024-00388
  • Ages > 18
  • Female

Study Summary

The goal of this observational study is to compare, in real-world clinical practice, the effect of fremanezumab on menstrual migraine to the effect of fremanezumab on non-perimenstrual attacks. The main question it aims to answer is, if menstrually-related migraine attacks respond equally well to anti-CGRP mAb treatment with fremanezumab as non-menstrually-related attacks.

Participants diagnosed with episodic or chronic migraine with menstrually-related migraine with or without aura and treated with fremanzumab according to the SmPC will be required to maintain a headache diary over at least 3 months prior to and 6 months after fremanezumab initiation.

Eligibility Criteria

Inclusion

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 InternationalHeadache Society (IHS) Classification (ICHD-3 code A1.1.2 or A1.2.0.2) for at leastone year.

  • Women suffering of at least 2 days of menstrually-related migraine per period onaverage in the last three periods (baseline measurements and inclusion criteria).

  • The patient has been maintaining a daily headache diary as part of her routinedisease management per her treating physician and has 3 months headache diary dataprior to baseline/ treatment initiation. Notes: The patient's headache diarycaptures information on each headache day, headache duration, headache severity,medication intake, each day of menstrual bleeding, pain intensity of symptomsassociated 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 forthe course of the study.

  • Initiation of anti-CGRP mAb (fremanezumab) treatment according to the Summary ofProduct Characteristics (SmPC) during clinical routine as a treatment of theirphysician (no study-specific intervention). This means that patients have to fulfilcriteria for treatment with anti-CGRP mAbs in Switzerland, i.e. they have at least 8days of migraine per month in the last three months.

  • The patient has signed the informed consent.

Exclusion

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 migrainemedication 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.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Fremanezumab
Phase:
Study Start date:
April 09, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Department of Neurology, Inselspital

    Bern, 3010
    Switzerland

    Active - Recruiting

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