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Monoclonal Antibodies

Patients receiving active medication for Migraine

Phase 4

Waitlist Available

Led By Carolyn M 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

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

Select...

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

Select...

I am a woman aged between 18 and 45.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Migraine Days

Secondary outcome measures

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 / 4Eligibility 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

1,609 Previous Clinical Trials

11,470,255 Total Patients Enrolled

4 Trials studying Migraine

485 Patients Enrolled for Migraine

Carolyn M Bernstein, MDPrincipal InvestigatorBrigham and Women's

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to become a participant in this clinical experimentation?

"Candidates between 18 and 45 years of age who experience migraines may be eligible to join the study. The trial seeks 72 participants in total."

Answered by AI

Are additional patients being sought for participation in this research?

"This clinical trial has already reached the enrollment limit and is not taking anymore patients. Initially posted on January 1st 2024, this study was last updated in December 7th 2023. Fortunately, there are still 192 other studies searching for participants at present moment."

Answered by AI

Does this research project include participants of 18 years or older?

"As per the provisions of this medical trial, only those aged 18-45 can be included in this research study."

Answered by AI

How secure is the process of administering active medication to individuals?

"Based on the Phase 4 trial, our team at Power grades the safety of individuals taking active medication with a 3 because this treatment has already been approved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Carolyn A. Bernstein 2024. "Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06173661.

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