Fremanezumab for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether the migraine treatment fremanezumab can also improve sleep quality for migraine sufferers. Fremanezumab is already approved for preventing migraines, but researchers aim to determine if fewer migraines correlate with better sleep. The trial involves regular assessments of migraines and sleep over several months. It seeks participants aged 18 to 65 who began experiencing migraines before age 50, have 10 to 25 headache days per month, and frequently encounter sleep troubles. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you do not start or change the type, dosage, or frequency of any preventive medications for conditions other than migraine that might affect the study, such as antidepressants or beta-blockers. If you are currently on a migraine preventative therapy, you cannot participate in the trial.
What is the safety track record for fremanezumab?
Research has shown that fremanezumab is generally safe for people with migraines. In various studies, patients tolerated fremanezumab well. Long-term use not only reduced the number of migraine days but also caused few side effects. Most people did not experience serious negative reactions to the treatment.
In another study, fremanezumab significantly lowered the number of monthly migraine and headache days compared to a placebo (a treatment with no active medicine). This demonstrates the treatment's effectiveness and safety over time. Additionally, the FDA has approved fremanezumab for preventing migraines, which further supports its safety for this condition.12345Why are researchers enthusiastic about this study treatment?
Fremanezumab is unique because it targets a specific protein involved in migraine attacks called calcitonin gene-related peptide (CGRP). Unlike traditional migraine treatments that often focus on relieving symptoms after they start or use general pain relief methods, fremanezumab works by preventing migraines from occurring in the first place. This targeted approach means fewer headaches and improved quality of life for patients. Researchers are excited because fremanezumab offers a more precise way to manage migraines with potentially fewer side effects than existing treatments.
What is the effectiveness track record for fremanezumab in treating migraines?
Research has shown that fremanezumab effectively prevents migraines. Studies found that over 66% of individuals with occasional migraines and 51.6% with frequent migraines experienced at least a 50% reduction in their monthly migraine days. Additional evidence confirms that fremanezumab decreases both the frequency and severity of migraines over time. This treatment targets a specific protein involved in migraine attacks, helping to prevent them before they start. These positive effects have consistently appeared in real-world use, demonstrating a strong track record for this medication.46789
Who Is on the Research Team?
Sait Ashina, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
Adults aged 18-65 with migraines, experiencing 10-25 headache days a month, at least 8 being migraine days lasting over 4 hours if untreated. Must score ≥10 on the Insomnia Severity Index but not have severe sleep disorders like obstructive sleep apnea or restless legs syndrome. Cannot be using certain pain or sleep medications regularly, have serious heart/cerebrovascular conditions, history of substance abuse within last 5 years, or be pregnant/nursing without birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete daily assessments of migraine and sleep outcomes before treatment
Treatment
Participants receive fremanezumab injections and are monitored for migraine and sleep outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fremanezumab
Fremanezumab is already approved in United States, European Union, United Kingdom for the following indications:
- Prevention of migraines in adults
- Prevention of migraines in adults
- Prevention of migraines in adults
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Teva Pharmaceuticals USA
Industry Sponsor
Dr. Eric A. Hughes
Teva Pharmaceuticals USA
Chief Medical Officer since 2022
MD and PhD from Yale School of Medicine
Richard Francis
Teva Pharmaceuticals USA
Chief Executive Officer since 2023
BSc in Biochemistry from Imperial College London