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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
Drug Has Already Been Approved
Pivotal Trial

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 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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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
1,666 Previous Clinical Trials
11,841,552 Total Patients Enrolled
Carolyn A Bernstein, MDPrincipal InvestigatorBrigham and Women's
~43 spots leftby Jan 2026
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