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

NCT06173661 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023p002389
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Menstrual Migraine; Menstrually Related Migraine

Outcome Measures

Primary Outcomes (1)

• Migraine Days

  The number of active migraine days during the 24-week treatment period after the 1st dose of study drug.

  6 months

Secondary Outcomes (10)

• Migraine Duration

  6 months

• Migraine Severity

  6 months

• Migraine Specific Quality of Life Measure

  6 months

• Responder Status

  6 months

• Disability (MIDAS)

  6 months

Study Arms (2)

Patients receiving active medication

ACTIVE COMPARATOR

These patients will receive 675 mg of fremanezumab for two total doses administered 3 months apart.

Drug: Fremanezumab

Patients receiving placebo

PLACEBO COMPARATOR

These patients will receive placebo injections for two total doses administered 3 months apart.

Other: Placebo

Interventions

Fremanezumab DRUG

The intervention will be active medication.

Also known as: AJOVY

Patients receiving active medication

Placebo OTHER

The intervention will be placebo injection.

Patients receiving placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients may be randomized in this study only if they meet all of the following criteria:
• The patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol
• The patient is female aged 18 to 45 years of age, inclusive
• The patient has a diagnosis of pure menstrual migraine (MM) or menstrual-related migraine (MRM)
• Prior to the screening visit (V1) the patient has a 6 month history of either:
• Menstrual Migraine (MM)
• Headache consistent with Menstrual Migraine (MM)
• Menstrually-Related Migraine (MRM)
• The patient fulfils the following criteria for migraine in a prospectively collected diary during the 28-day baseline period:
• ○ Migraine attacks starting in the peri-menstrual period (days -2 to +3 of menstruation)
• AND
• Pure Menstrual migraine with aura, either/or
• Menstrually-related migraine with aura, either/or
• Pure Menstrual migraine without aura, either/or
• Menstrually-related migraine without aura

You may not qualify if:

• Patients will not be randomized/enrolled in this study if they meet any of the following criteria:
• The patient uses medications containing opioids or barbiturates on more than 4 days during the 28-day baseline period for the treatment of migraine or any other reason
• The patient uses \>8 rimegepant or ubrogepant tablets per month
• The patient has ≥15 headache days per month
• The patient has used am intervention/device (eg, scheduled nerve blocks, implantable vagal nerve stimulation, and transcranial magnetic stimulation) for migraine during the 2 months prior to screening
• The patient is overusing acute medication
• The patient is pregnant or lactating or planning to get pregnant in ≤13 months post screening visit (V1)
• The patient has clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic or ocular disease, at the discretion of the sponsor
• The patient has a history of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[eg, cerebral ischemia\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
• The patient has a known infection or history of human immunodeficiency virus, tuberculosis, any history of Lyme disease, or chronic hepatitis B or C infection
• The patient has a past or current history of cancer, except for appropriately treated non-melanoma skin carcinoma
• The patient has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies
• The patient has participated in a clinical study of a new chemical entity or a prescription medicine within 2 months of the screening visit (V1) or 3 months in case of biologics if the half-life of the biologics is unknown or 5 half-lives, whichever is longer, or is currently participating in another study of an IMP (or a medical device)
• The patient has previously received treatment with any calcitonin generelated peptide pathway (ligand/receptor) target therapy(erenumab, eptinezumab, galcanezumab, fremanezumab, rimegepant 75 mg every other day, or atogepant) or is actively taking them during the study
• The patient has any finding in the baseline 12-lead electrocardiogram considered clinically significant in the judgment of the sponsor

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Brigham and Women's Health Care Center

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab; erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Carolyn A Bernstein, MD

  Brigham and Women's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A research pharmacist who is not on the study team will randomize the study arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, single center, double blind, placebo-controlled clinical trial with a non-crossover, parallel group study design that will select 72 patients who meet criteria and randomize half to receive active medication and half to receive placebo. A research pharmacist will randomize the patients; the study team will be blinded.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 18, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)