Migraine > Fremanezumab

Fremanezumab for Menstrual Migraine

Recruiting in Palo Alto (17 mi)

Overseen By Carolyn A Bernstein, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Brigham and Women's Hospital

Must not be taking: Opioids, Barbiturates, CGRP therapies, others

Disqualifiers: Pregnancy, Cardiovascular disease, Cancer, others

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

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 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.

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.

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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.

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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.

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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.

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.

Trial 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

Participant Groups

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.

Group I: Patients receiving active medication Active Control 1 Intervention

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

Group II: Patients receiving placebo Placebo Group 1 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

Research Locations Nearby Select from list below to view details:

Brigham and Women's Health Care Center Chestnut Hill, MA

Who Is Running the Clinical Trial?

Brigham and Women's Hospital Lead Sponsor

Teva Pharmaceuticals USA Industry Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of fremanezumab for chronic migraine prevention: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. [2022] To determine the efficacy and safety of fremanezumab administration in Japanese and Korean patients with chronic migraine (CM).

2. New Zealand pubmed.ncbi.nlm.nih.gov

Fremanezumab: First Global Approval. [2019] Fremanezumab-vfrm (hereafter referred to as fremanezumab) [AJOVY™] is a fully humanized monoclonal antibody (IgG2Δa) developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine). Its use has been associated with significant reductions in migraine frequency, the requirement for acute headache medication use and headache-related disability compared with placebo in multinational, phase III studies, and in September 2018 fremanezumab was approved by the US FDA for the preventive treatment of migraine in adults. A regulatory assessment for fremanezumab as a preventive treatment of migraine in adults is underway in the EU. Fremanezumab is also undergoing phase III development for the preventive treatment of cluster headache (although a phase III chronic cluster headache study has been suspended due to the results of a prespecified futility analysis) and phase II development for the preventive treatment of post-traumatic headache disorder. This article summarizes the milestones in the development of fremanezumab leading to this first approval in the USA for the preventive treatment of migraine in adults.

3. England pubmed.ncbi.nlm.nih.gov

Fremanezumab autoinjector pen for the prevention of migraine. [2022] Ajovy (fremanezumab, Teva Pharmaceuticals, Israel) is a fully humanized monoclonal antibody that selectively binds both isoforms of the calcitonin gene-related peptide. Calcitonin gene-related peptide is a 37-amino acid neuropeptide involved in central and peripheral pathophysiological events in migraine. It is indicated for prophylaxis of migraine in adults who have at least four migraine days per month, and can be administered as a subcutaneous injection using an autoinjector device, with two dosing options: 225 mg once a month or 675 mg quarterly. In this article, I present data from Phase III clinical trials of fremanezumab in episodic and chronic migraine, in which fremanezumab demonstrated efficacy and had a favorable tolerability profile, with no serious treatment-related adverse events.

4. United States pubmed.ncbi.nlm.nih.gov

Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. [2022] Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed against calcitonin-gene-related peptide (CGRP), a validated target for migraine preventive therapy. In two previous phase 2 studies, fremanezumab administered once every 28 days for 12 weeks was found to be effective and safe as a preventive treatment for patients suffering from episodic migraine (EM) and chronic migraine (CM).

5. United States pubmed.ncbi.nlm.nih.gov

Reduction in the severity and duration of headache following fremanezumab treatment in patients with episodic and chronic migraine. [2021] To evaluate the impact of fremanezumab on the severity and duration of remaining migraine attacks in patients with chronic migraine (CM) or episodic migraine (EM).

6. United States pubmed.ncbi.nlm.nih.gov

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] We evaluated galcanezumab for migraine prevention in patients who met International Classification of Headache Disorders, 3rd edition criteria for menstrually related migraine (MRM).

7. England pubmed.ncbi.nlm.nih.gov

Fremanezumab blocks CGRP induced dilatation in human cerebral, middle meningeal and abdominal arteries. [2019] Fremanezumab (TEV-48125) is a fully humanized anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) that has shown positive results in the prevention of episodic migraine and chronic migraine. Previous preclinical studies have revealed CGRP antagonistic effects on intracranial arteries (ICA). The aim of the study was to evaluate the in vitro antagonistic effects of fremanezumab on human arteries.

8. United States pubmed.ncbi.nlm.nih.gov

Delayed Injection Site Reaction to Fremanezumab for Chronic Migraine Treatment. [2023] Fremanezumab is a humanized monoclonal antibody administered through a subcutaneous injection. It is used for treatment of migraines, and occasional injection site reactions have developed after usage.