Actively Recruiting

Age: 18Years +
FEMALE
ID06659120

Fremanezumab for the Prevention of Menstrually-related Migraine Attacks A Prospective, Observational Study According to Routine Neurological Care in Switzerland

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-10-26

120

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how the drug fremanezumab affects menstrual migraine attacks compared to non-menstrual migraine attacks in real-world clinical practice. This observational study focuses on premenopausal women diagnosed with episodic or chronic migraine who experience menstrually-related migraine, with or without aura. The main goal is to find out if menstrual migraine attacks respond as well to fremanezumab as other migraine attacks. Patients are treated according to routine care and criteria for anti-CGRP mAb treatment in Switzerland. Participants will receive fremanezumab treatment following standard medical guidelines, with no additional study-specific interventions. Women included are those with a regular menstrual cycle and a history of migraines for at least one year, having at least eight migraine days per month and at least two days of menstrually-related migraine per cycle. The study requires maintaining a detailed headache diary for at least three months before starting fremanezumab and six months after treatment initiation. During the study, participants will keep a daily headache diary recording headache details, medication use, menstrual bleeding, and symptoms related to endometriosis if present. Researchers will measure changes in the number of migraine days per month over six months, as well as changes in disability, quality of life, anxiety, depression, fatigue, and hormonal treatment use. The study is observational, with no experimental treatments beyond routine care, and will last at least six months from the start of fremanezumab treatment.

CONDITIONS

Brief Title

Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Premenopausal women of 18 years of age or older.
  • Women with a regular cycle 21-32 days.
  • Diagnosis of chronic or episodic migraine.
  • Migraine with or without aura according to International Headache Society Classification for at least one year.
  • At least 2 days of menstrually-related migraine per period on average in the last three periods.
  • Maintaining a daily headache diary for at least 3 months prior to treatment.
  • Willingness to keep a headache diary throughout the study.
  • Initiation of anti-CGRP mAb (fremanezumab) treatment according to clinical routine and criteria.
  • Signed informed consent.
Not Eligible

You will not qualify if you...

  • Pure menstrual migraine.
  • Treatment with another anti-CGRP mAb.
  • Not treated with fremanezumab according to the Summary of Product Characteristics.
  • 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 of hormone therapy during study treatment.
  • Use of progestin-only contraception.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive fremanezumab treatment as prescribed by their physician according to routine clinical care.

Visits as part of routine neurological care; frequency determined by treating physician

Follow-up

Duration - 6 months

Participants are monitored for changes in migraine frequency and related symptoms after treatment initiation.

Regular assessments as part of routine care during the treatment period

Trial Site Locations

Total: 1 location

1

Department of Neurology, Inselspital

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

C

Christoph J Schankin, Prof

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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Published Research Related To This Trial

Both perimenstrual and nonperimenstrual migraine days respond to anti-calcitonin gene-related peptide (receptor) antibodies.

Iris E Verhagen, Simone de Vries Lentsch, Britt W H van der Arend...

https://pubmed.ncbi.nlm.nih.gov/36941533