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Monoclonal Antibodies

Fremanezumab for Menstrual Migraine

Phase 4

Recruiting

Led By Carolyn A Bernstein, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient has a body weight ≥45 kg and a body mass index within the range of 17.5 to 34.9 kg/m^2, inclusive

The patient has a diagnosis of pure menstrual migraine (MM) or menstrual-related migraine (MRM)

Must not have

The patient has previously received treatment with certain therapies or is actively taking them during the study

The patient has a prior medical history of significant proteinuria or evidence of renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial studies if a migraine prevention medicine can help those w/ menstrual migraines. Participants receive meds & fill out diaries to compare results.

Who is the study for?

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.

What is being tested?

The study tests if fremanezumab, an injectable medication targeting the CGRP pathway, can reduce menstruation-related migraines. It involves comparing this drug with a placebo over two treatment sessions every three months.

What are the potential side effects?

Fremanezumab may cause injection site reactions (like pain or swelling), allergic reactions, and possibly other side effects not yet known due to its action on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 45 kg and my BMI is between 17.5 and 34.9.

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I have been diagnosed with migraines related to my menstrual cycle.

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I have recorded my migraine symptoms for 28 days showing I meet the migraine criteria.

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I am a woman aged between 18 and 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on or have been treated with specific therapies.

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I have had significant protein in my urine or kidney disease in the past.

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I have a serious health condition that is not under control.

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I experience headaches on 15 or more days each month.

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I have a history of liver problems.

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I use more than 8 migraine tablets a month.

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I have a history of heart disease or blood clots.

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I have a history of infectious diseases or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Migraine Days

Secondary study objectives

Anxiety (GAD-7)

Depression (PHQ-9)

Disability (HIT-6)

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Patients receiving active medicationActive Control1 Intervention

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

Group II: Patients receiving placeboPlacebo Group1 Intervention

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

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Teva Pharmaceuticals USAIndustry Sponsor

230 Previous Clinical Trials

188,136 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,653 Previous Clinical Trials

11,490,963 Total Patients Enrolled

4 Trials studying Migraine

485 Patients Enrolled for Migraine

Carolyn A Bernstein, MDPrincipal InvestigatorBrigham and Women's

~48 spots leftby Jan 2026

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