Health TrialsbyHealthPanel

Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

ConditionMenstrual Migraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Premenopausal women ≥18 years of age, diagnosed with episodic or chronic migraine, with menstrually-related migraine with or without aura according to IHS Classification (ICHD-3 code A1.1.2 or A1.2.0.2)\*, and have been prescribed fremanezumab according to the SmPC as a treatment decision of their physician and enrollment in this study at baseline.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Women with menstrually-related migraine attacks1 intervention

Trial outcomes

Primary outcomes

1

Change of migraine days per month

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).

Time frame
6 months

Secondary outcomes

1

Change of disability score MIDAS in points

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

Time frame
6 months
2

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

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

Time frame
6 months
3

Migraine-specific quality of life in MSQ score in points

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

Time frame
6 months
4

Anxiety in GAD-7 score, in points

Change from baseline in anxiety (GAD-7).

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Source ClinicalTrials.gov
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