Clinical Trial

Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45

Active, Not Recruiting Phase 4
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Record status
This record was last updated February 27, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
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 levels Researchers will compare the people who get the medicine to those who get the inactive substitute to see if there are differences in response.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-12-07; most recent amendment 2026-02-25.
Status change: Recruiting → Active, Not Recruiting 2026-02-25
Status change: Not Yet Recruiting → Recruiting 2024-05-14
Trial Details
NCT Number NCT06173661
Lead Sponsor Brigham and Women's Hospital
Collaborators: Teva Pharmaceuticals USA
Conditions Migraine, Menstrual Migraine, Menstrually Related Migraine
Enrollment 72 participants
Start Date 2024-03-01
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-27