Fremanezumab for the Prevention of Menstrually-related Migraine Attacks (FROMM)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Menstrual Migraine

Treatments: Drug: Fremanezumab

Study type: Observational

Funder types: Other

Identifiers

NCT06659120

2024-00388

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 1 patient group

Women with menstrually-related migraine attacks

Description:

* 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).

Treatment:

Drug: Fremanezumab