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NCT Number: NCT06659120

Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

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.

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Key information

Conditions

Menstrual Migraine

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Neurology, Inselspital

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Christoph J Schankin, Prof

CONTACT

[email protected]

00416322111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fremanezumab

Drug

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.

Primary outcomes

  1. Change of migraine days per month

    Time frame: 6 months

    Difference in relative reduction of migraine days per month between menstrually-related and non-menstrual migraine days at follow-up (months 4 to 6 after initiation of anti-CGRP mAb) compared to baseline (months -3 to -1 prior to initiation).

Secondary outcomes

  1. Change of disability score MIDAS in points

    Time frame: 6 months

    Change from baseline in disability score, as measured by the Migraine Disability Assessment (MIDAS) questionnaire, at month 6.

  2. Change of headache-related disability score HIT-6 in points

    Time frame: 6 months

    Headache-related disability score, as measured by the HIT-6, at month 6.

  3. Migraine-specific quality of life in MSQ score in points

    Time frame: 6 months

    Migraine-specific quality of life, as measured by the MSQ version 2.1, at month 6.

  4. Anxiety in GAD-7 score, in points

    Time frame: 6 months

    Change from baseline in anxiety (GAD-7).

  5. Depression in PHQ-8 score, in points

    Time frame: 6 months

    Change from baseline in depression (PHQ-8).

  6. Change of fatigue assessed by FSS in points

    Time frame: 6 months

    Change from baseline in sleep questionnaires at month 6 (Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS) and Insomnia Severity Index (ISI)).

  7. Endometriosis symptoms

    Time frame: 6 months

    Change from baseline in number of days per month and intensity with typical symptoms of endometriosis (dysmenorrhoea, dyschezia, dysuria and dyspareunia) in women who have menstrually-related migraine and endometriosis (subgroup) at follow-up (months 4 to 6 after initiation of anti-CGRP mAb) compared to baseline (months -3 to -1 prior to initiation). (Headache diary).

  8. Hormonal treatment

    Time frame: 6 months

    Change from baseline in number of migraine days in patients with and without concomitant hormonal treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph J Schankin, Prof

CONTACT

[email protected]

00416322111

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Fremanezumab for the Prevention of Menstrually-related Migraine Attacks - a Prospective, Observational Study According to Routine Neurological Care in Switzerland

Acronym: FROMM

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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