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

NCT06173661 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Migraine
  • Menstrual Migraine
  • Menstrually Related Migraine

Interventions

DRUG

Fremanezumab

The intervention will be active medication.

OTHER

Placebo

The intervention will be placebo injection.

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Carolyn A Bernstein, MD · Brigham and Women's

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173661 on ClinicalTrials.gov