72 Participants Needed

Fremanezumab for Menstrual Migraine

KP
MC
Overseen ByMelanie Choe
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not start any new migraine preventive medications during the study. However, it does not specify if you need to stop taking your current medications, so it's best to discuss this with the study team.

What data supports the effectiveness of the drug fremanezumab for treating menstrual migraine?

Fremanezumab has been shown to significantly reduce the frequency of migraines and the need for acute headache medication in adults with migraines. It is effective as a preventive treatment for both episodic and chronic migraines, which suggests it may also help with menstrual migraines.12345

Is fremanezumab safe for humans?

Fremanezumab has been shown to be generally safe in humans, with no serious treatment-related adverse events reported in clinical trials for migraine prevention.12346

How is the drug fremanezumab unique for treating menstrual migraine?

Fremanezumab is unique because it is a monoclonal antibody that targets a specific protein involved in migraines, called calcitonin gene-related peptide (CGRP), and is administered as a subcutaneous injection, offering a preventive approach rather than treating symptoms after they occur.23478

What is the purpose of this trial?

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 levelsResearchers will compare the people who get the medicine to those who get the inactive substitute to see if there are differences in response.

Research Team

CA

Carolyn A Bernstein, MD

Principal Investigator

Brigham and Women's

Eligibility Criteria

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.

Inclusion Criteria

I weigh at least 45 kg and my BMI is between 17.5 and 34.9.
I can sign and follow the study's rules.
I have been diagnosed with migraines related to my menstrual cycle.
See 7 more

Exclusion Criteria

The patient is overusing acute medication
The patient has participated in a clinical study of a new chemical entity or a prescription medicine within a specified timeframe
I am currently on or have been treated with specific therapies.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive fremanezumab or placebo injections every three months for two treatments, with monitoring through diaries and hormone level tests

6 months
3 visits (in-person), 5 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of migraine days, severity, and quality of life

4 weeks

Treatment Details

Interventions

  • Fremanezumab
Trial Overview 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.
Participant Groups
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.

Fremanezumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as Ajovy for:
  • Prevention of migraines in adults
🇪🇺
Approved in European Union as Ajovy for:
  • Prevention of migraines in adults
🇬🇧
Approved in United Kingdom as Ajovy for:
  • Prevention of migraines in adults

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Teva Pharmaceuticals USA

Industry Sponsor

Trials
232
Recruited
189,000+

Dr. Eric A. Hughes

Teva Pharmaceuticals USA

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis profile image

Richard Francis

Teva Pharmaceuticals USA

Chief Executive Officer since 2023

BSc in Biochemistry from Imperial College London

Findings from Research

Fremanezumab significantly reduced the average number of moderate to severe headache days in Japanese and Korean patients with chronic migraine, showing a reduction of 4.1 days per month compared to 2.4 days for placebo over 12 weeks.
The treatment was well tolerated, with a similar rate of adverse events, including injection-site reactions, compared to placebo, indicating a favorable safety profile.
Efficacy and safety of fremanezumab for chronic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients.Sakai, F., Suzuki, N., Kim, BK., et al.[2022]
Fremanezumab is a fully humanized monoclonal antibody that targets calcitonin gene-related peptide, which plays a key role in migraine pathophysiology, and has shown significant reductions in migraine frequency and related disability in phase III studies involving adults.
Approved by the US FDA in September 2018 for preventive migraine treatment, fremanezumab is also being explored for cluster headaches and post-traumatic headache disorder, although a study for chronic cluster headaches was suspended due to futility analysis results.
Fremanezumab: First Global Approval.Hoy, SM.[2019]
Ajovy (fremanezumab) is an effective monoclonal antibody for preventing migraines, showing positive results in Phase III clinical trials for both episodic and chronic migraine sufferers.
The treatment has a favorable safety profile, with no serious adverse events reported, making it a promising option for adults experiencing frequent migraines.
Fremanezumab autoinjector pen for the prevention of migraine.Weatherall, MW.[2022]

References

Efficacy and safety of fremanezumab for chronic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. [2022]
Fremanezumab: First Global Approval. [2019]
Fremanezumab autoinjector pen for the prevention of migraine. [2022]
Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. [2022]
Reduction in the severity and duration of headache following fremanezumab treatment in patients with episodic and chronic migraine. [2021]
Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. [2023]
Fremanezumab blocks CGRP induced dilatation in human cerebral, middle meningeal and abdominal arteries. [2019]
Delayed Injection Site Reaction to Fremanezumab for Chronic Migraine Treatment. [2023]
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