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
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 design
Treatments tested in this trial
- Fremanezumab
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov