Actively Recruiting
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-10-26
120
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women 18 years or older
- Regular menstrual cycle of 21 to 32 days
- Diagnosis of chronic or episodic migraine
- Migraine with or without aura for at least one year according to International Headache Society classification
- At least 2 days of menstrually-related migraine per menstrual period on average over the last three periods
- Maintained a daily headache diary for at least 3 months prior to treatment
- Willingness to keep a headache diary throughout the study
- Starting treatment with fremanezumab according to approved guidelines with at least 8 migraine days per month in the last three months
- Signed informed consent
You will not qualify if you...
- Pure menstrual migraine only
- Treatment with another anti-CGRP monoclonal antibody
- Not treated with fremanezumab according to approved guidelines
- Use of other anti-CGRP-based preventive migraine medication within 6 months before enrollment
- Participation in an interventional clinical trial for episodic or chronic migraine
- Change in hormone therapy during the study
- Use of progestin-only contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Neurology, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
C
Christoph J Schankin, Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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