100 Participants Needed

Fremanezumab for Migraine

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Overseen ByTolu ajayi
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

SA

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

I have been diagnosed with migraine, following official guidelines.
Able to provide written informed consent
I agree not to change my preventive medications unless it's for migraines.
See 4 more

Exclusion Criteria

You have a history of feeling very scared in small, enclosed spaces.
I am currently taking prescription pain medication for headaches or body pain.
I have had a stroke, TIA, or surgery on the arteries in my neck.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0-30 days
1 visit (in-person)

Baseline

Participants complete daily assessments of migraine and sleep outcomes before treatment

0-30 days
Daily assessments

Treatment

Participants receive fremanezumab injections and are monitored for migraine and sleep outcomes

3 months
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Fremanezumab
Trial Overview The trial is testing Fremanezumab's effect on preventing migraines and improving sleep quality in patients with frequent migraines. Participants will self-report daily assessments of migraine and sleep before treatment and for three months after starting treatment to see if there are changes in their condition.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: treatment effectExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Ajovy for:
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Approved in European Union as Ajovy for:
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Approved in United Kingdom as Ajovy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

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

Published Research Related to This Trial

Fremanezumab, a monoclonal antibody targeting CGRP, significantly reduced the number of migraine days in patients with episodic and chronic migraines who were already on stable preventive medications, showing a reduction of 12.4 days compared to 7.4 days for placebo.
The treatment was found to be safe, with mostly mild and transient side effects, and no serious adverse events linked to the treatment, indicating it can be a reliable add-on therapy for migraine prevention.
Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines.Cohen, JM., Dodick, DW., Yang, R., 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]
Temozolomide (TMZ) and bevacizumab (BEV) are effective chemotherapeutic agents for treating high-grade gliomas, but their mechanisms of action can vary, with TMZ potentially inducing cell death through apoptosis or autophagy, while BEV may cause cell death via hypoxia-induced autophagy.
Clinical trials indicate that newly diagnosed glioma patients have a longer overall survival (12-15 months) compared to those with recurrence (8-9 months), suggesting that combining TMZ with radiotherapy and BEV may enhance treatment efficacy, although further clinical trials are needed to determine the best treatment regimen.
Current evidence of temozolomide and bevacizumab in treatment of gliomas.Nanegrungsunk, D., Onchan, W., Chattipakorn, N., et al.[2022]

Citations

Final Data from Teva's PEARL Real-World Study Reinforce ...The final analysis of the PEARL real-world study reaffirms the long-term effectiveness and safety profile of fremanezumab in the preventive treatment of ...
Real-World Data Show Sustained Migraine Benefit With ...The final study revealed that over 66% of patients with EM and 51.6% with CM who had achieved the primary endpoint of a ≥50% reduction in MMD ...
Efficacy Results for Episodic Migraine from Clinical TrialsIn clinical trials, AJOVY reduced migraine days by 50% or more for some patients ... Long-term safety, tolerability, and efficacy of fremanezumab in migraine: a ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38889289/
Effectiveness of fremanezumab treatment in patients with ...Significant reductions in monthly migraine days, headache days, and days requiring acute medication were observed in those with episodic and ...
Phase 4 PEARL Study Confirms Long-Term Effectiveness ...Fremanezumab shows significant long-term effectiveness in reducing migraine frequency and severity, enhancing patient outcomes in chronic and episodic cases.
Final Data from Teva's PEARL Real-World Study Reinforce ...that over 66% of patients with EM and 51.6% with CM who had achieved the primary endpoint of a ≥50% reduction in Monthly Migraine Days (MMD) ...
Teva Presents Positive Efficacy and Safety Data of AJOVY ...AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period ...
Long-term safety, tolerability, and efficacy of ...Long-term fremanezumab treatment was well tolerated and resulted in sustained improvements in monthly migraine days, headache days, and headache-related ...
NCT02621931 | Comparing Efficacy and Safety of 2 Dose ...Efficacy and safety of fremanezumab in clinical trial participants aged >/=60 years with episodic or chronic migraine: pooled results from 3 randomized ...
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