Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-28 @ 12:32 PM
Study NCT ID:
NCT06173661
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2023-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Patients who meet the eligibility criteria and wish to participate will be consented, and will then be randomized to receive two rounds of treatment with either fremanezumab or placebo, administered 3 months apart, to understand efficacy and response in decreasing migraine days. The investigators will monitor with daily logs and use evidenced metrics to assess response. Participants will be carefully screened to ensure that they do not become pregnant while in the study. The investigators will measure monthly hormone levels using salivary samples. Each participant will have three in-person visits and will have five 5 visits via secure telehealth. The investigators are studying decreased headache days, severity, disability and quality of life.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: