Fremanezumab for Preventing Chronic Migraine

Recruiting at 93 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

298 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab The total duration of the study is planned to be 75 months.

Research Team

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Fremanezumab Experimental Treatment 1 Intervention

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

Group II: 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