Fremanezumab for Preventing Chronic Migraine

No longer recruiting at 98 trial locations

Overseen By Teva U.S. Medical Information

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Must not be taking: Opioids, Barbiturates, Lamotrigine, others

Disqualifiers: Psychiatric conditions, Infections, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests fremanezumab, a medication aimed at preventing chronic migraines. Researchers aim to determine its effectiveness compared to a placebo (a harmless pill with no active medicine). The trial also evaluates the safety of fremanezumab and the body's reaction to it. Individuals who have experienced migraines for at least six months and suffer from headaches on 15 or more days a month might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new migraine treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use medications containing opioids or barbiturates for migraines during the 3 months before the screening. It's best to discuss your specific medications with the trial investigator.

Is there any evidence suggesting that fremanezumab is likely to be safe for humans?

Research has shown that fremanezumab is safe for preventing migraines. In a large study with over 2,800 patients, fremanezumab was well-tolerated, with most participants experiencing no problems. The study found no major side effects related to the heart or brain.

Another study supported these findings, demonstrating that fremanezumab reduced the number of migraine days without causing serious side effects. These studies suggest that fremanezumab is both effective and safe for most people. For those considering participation in a clinical trial, this information may provide reassurance about the safety of fremanezumab. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic migraine?

Fremanezumab is unique because it targets a protein called CGRP (calcitonin gene-related peptide) that plays a key role in migraine attacks. Unlike traditional migraine treatments like triptans, which work by constricting blood vessels, fremanezumab works by binding to CGRP and preventing it from causing inflammation and pain. Researchers are excited because this approach could offer a new option for those who don't respond well to existing treatments, and it may result in fewer side effects. By being administered via a simple subcutaneous injection, it also promises convenience and ease for patients managing chronic migraines.

What evidence suggests that fremanezumab could be an effective treatment for chronic migraine?

Research has shown that fremanezumab, which participants in this trial may receive, can reduce the number of migraine days for many people. In real-world studies, about 51.6% of patients with chronic migraines experienced a reduction of half or more in their monthly migraine days. This represents a significant improvement in managing migraines. Additionally, these studies confirm that fremanezumab is safe and well-tolerated over the long term. This information highlights the treatment's potential to assist those dealing with frequent migraines. ^{1 6 7 8 9}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

This trial is for young patients aged 6 to 17 who suffer from chronic migraines, experiencing at least 8 migraines and a total of 15 headaches per month. They should have been on stable migraine medication for two months and diagnosed with migraines over six months ago. Caregivers can apply for their children if they commit to daily headache tracking.

Inclusion Criteria

I am willing to keep a daily headache diary during the study.

The participant or parent/caregiver maintain a prospectively collected headache diary

I was diagnosed with migraines over 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Fremanezumab or placebo subcutaneously monthly for 3 months

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Fremanezumab

Trial Overview The study tests the effectiveness of Fremanezumab against a placebo in preventing chronic migraines in young patients. Participants will be randomly assigned to receive either the actual drug or a placebo, and the trial will last up to four years.

How Is the Trial Designed?

Group I: Fremanezumab Dose B Experimental Treatment 1 Intervention

Participants weighing ≥ threshold will receive Dose B subcutaneously monthly for 3 months.

Group II: Fremanezumab Dose A Experimental Treatment 1 Intervention

Participants weighing \< threshold will receive Dose A subcutaneously monthly for 3 months.

Group III: Placebo Placebo Group 1 Intervention

Matching placebo

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

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Citations

1. tevapharm.com tevapharm.com/news-and-media/latest-news/final-data-from-tevas-pearl-real-world-study-reinforce-the-long-term-effectiveness-of-ajovy-fremanezum/

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 ...

2. uspharmacist.com uspharmacist.com/article/realworld-data-show-sustained-migraine-benefit-with-ajovy

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 ...

3. ajovyhcp.com ajovyhcp.com/efficacy/episodic-migraine

Efficacy Results for Episodic Migraine from Clinical Trials In 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.gov pubmed.ncbi.nlm.nih.gov/39775579/

Results From a Retrospective Chart Review Conclusion: The addition of fremanezumab preventively to gepants for acute migraine treatment was effective, resulted in fewer outpatient office visits, and ...

5. neurologylive.com neurologylive.com/view/phase-4-pearl-study-confirms-long-term-effectiveness-fremanezumab-preventing-chronic-episodic-migraine

Phase 4 PEARL Study Confirms Long-Term Effectiveness ... Results showed that fremanezumab met its primary end point, with 66% of patients with EM and 51.6% of those with CM achieving at least a 50% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9218411/

Safety and tolerability of fremanezumab in patients with ... Fremanezumab demonstrated a favorable overall and cardio- and cerebrovascular safety profile in more than 2800 patients with episodic migraine or chronic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02621931

NCT02621931 | Comparing Efficacy and Safety of 2 Dose ... The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine.

8. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-Positive-Efficacy-and-Safety-Data-of-AJOVY-fremanezumab-for-the-Prevention-of-Episodic-Migraine-in-Children-and-Adolescents-from-Phase-3-SPACE-Trial/default.aspx

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 ...

9. ajovy.com ajovy.com/ajovyhcp080725/efficacy/chronic-migraine/

Efficacy Results for Chronic Migraine from Clinical Trials In clinical trials, AJOVY reduced migraine days by 50% or more for some patients · SECONDARY ENDPOINT · EXPLORATORY ANALYSIS · EXPLORATORY ANALYSIS · IMPORTANT ...