Phase
Condition
Migraine And Cluster Headaches
Migraine (Adult)
Menstrual Disorders
Treatment
Fremanezumab
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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 InternationalHeadache Society (IHS) Classification (ICHD-3 code A1.1.2 or A1.2.0.2) for at leastone year.
Women suffering of at least 2 days of menstrually-related migraine per period onaverage in the last three periods (baseline measurements and inclusion criteria).
The patient has been maintaining a daily headache diary as part of her routinedisease management per her treating physician and has 3 months headache diary dataprior to baseline/ treatment initiation. Notes: The patient's headache diarycaptures information on each headache day, headache duration, headache severity,medication intake, each day of menstrual bleeding, pain intensity of symptomsassociated 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 forthe course of the study.
Initiation of anti-CGRP mAb (fremanezumab) treatment according to the Summary ofProduct Characteristics (SmPC) during clinical routine as a treatment of theirphysician (no study-specific intervention). This means that patients have to fulfilcriteria for treatment with anti-CGRP mAbs in Switzerland, i.e. they have at least 8days of migraine per month in the last three months.
The patient has signed the informed consent.
Exclusion
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 migrainemedication 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.
Study Design
Connect with a study center
Department of Neurology, Inselspital
Bern, 3010
SwitzerlandActive - Recruiting
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