Fremanezumab for Menstrual Migraine
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you do not start any new migraine preventive medications during the study. However, it does not specify if you need to stop taking your current medications, so it's best to discuss this with the study team.
What data supports the effectiveness of the drug fremanezumab for treating menstrual migraine?
Is fremanezumab safe for humans?
How is the drug fremanezumab unique for treating menstrual migraine?
What is the purpose of this trial?
The goal of this clinical trial is to learn about how a migraine prevention medicine works for people who have migraines/headaches with their menstrual period. The study includes people ages 18 to 45 who have been diagnosed with migraine and who have a migraine with their menstrual period or those who have migraines with their menstrual period and at other times of the month as well.The main question the study aims to answer are:• Does fremanazemab, an injectable calcitonin gene-related peptide (CGRP) pathway targeting therapy, decrease migraines associated with menstruation?Participants will* have an evaluation and examination by a headache specialist physician* will receive the study medicine or inactive substitute every three months for two treatments* fill out diaries about their migraines* have tests on saliva to measure hormone levelsResearchers will compare the people who get the medicine to those who get the inactive substitute to see if there are differences in response.
Research Team
Carolyn A Bernstein, MD
Principal Investigator
Brigham and Women's
Eligibility Criteria
This trial is for women aged 18-45 who suffer from migraines during their menstrual period. Participants should have a diagnosis of migraine, which can also occur at other times of the month. They must be willing to receive injections, keep a diary on their headaches, and provide saliva samples.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fremanezumab or placebo injections every three months for two treatments, with monitoring through diaries and hormone level tests
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of migraine days, severity, and quality of life
Treatment Details
Interventions
- Fremanezumab
Fremanezumab is already approved in United States, European Union, United Kingdom for the following indications:
- Prevention of migraines in adults
- Prevention of migraines in adults
- Prevention of migraines in adults
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Teva Pharmaceuticals USA
Industry Sponsor
Dr. Eric A. Hughes
Teva Pharmaceuticals USA
Chief Medical Officer since 2022
MD and PhD from Yale School of Medicine
Richard Francis
Teva Pharmaceuticals USA
Chief Executive Officer since 2023
BSc in Biochemistry from Imperial College London