NCT06659120 Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
| NCT ID | NCT06659120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Menstrual Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-04-09 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Christoph J Schankin, Prof
PRINCIPAL INVESTIGATOR
Inselspital, Department of Neurology, Bern
Frequently Asked Questions
Who can join the NCT06659120 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Menstrual Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06659120 currently recruiting?
Yes, NCT06659120 is actively recruiting participants. Contact the research team at christoph.schankin@insel.ch for enrollment information.
Where is the NCT06659120 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06659120 clinical trial?
NCT06659120 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Christoph J Schankin, Prof at Inselspital, Department of Neurology, Bern. The trial plans to enroll 120 participants.
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