Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
Recruiting
Observational Study
Menstrual Migraine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
120 (estimated)
Sponsor
Insel Gruppe AG, University Hospital Bern · Other
Who this trial is looking for
This trial is looking for women who have menstrual migraine and are at least 18 years old. Participants will take fremanezumab and keep a headache diary for several months before and after starting the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 18 or older.
I have a regular menstrual cycle of 21-32 days.
I have been diagnosed with chronic or episodic migraine.
I have had migraine with or without aura for at least one year.
I experience at least 2 days of menstrual migraine during my last three periods.
I have been keeping a daily headache diary for at least 3 months.
I understand and will keep records in my headache diary for this trial.
I am starting treatment with fremanezumab as advised by my doctor.
You may not be able to join if
I have pure menstrual migraine.
I am being treated with another anti-CGRP mAb.
I am not receiving fremanezumab according to the treatment guidelines.
I have used another anti-CGRP-based preventive medication in the last 6 months.
I am taking part in another clinical trial for migraine.
I have changed my hormone therapy during the study.
I use progestin-only contraception.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility Criteria
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-…
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.
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