← Back to Search

Monoclonal Antibodies

Fremanezumab for Preventing Chronic Migraine

Verified Trial
Phase 3
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you experienced 8 migraines in the past month?
Have you been using the same migraine medication for the past two months?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 1, and month 3
Awards & highlights

Study Summary

This trial will compare the effects of a new migraine prevention drug, fremanezumab, to a placebo. The study will last 48 months and will look at safety, effectiveness, and antibody response.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with similar medications include injection site reactions, allergic reactions, fatigue, nausea, and potential long-term immunogenicity issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have experienced 8 migraines in the past month.
Select...
The participant or parent/caregiver maintain a prospectively collected headache diary
Select...
I am willing to keep a daily headache diary during the study.
Select...
I have had 15 headaches in the past month.
Select...
I was diagnosed with migraines over 6 months ago.
Select...
I am applying for this trial as my child's caregiver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 1, and month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, and month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in the monthly average number of headache days of at least moderate severity after the first dose of study drug
Secondary outcome measures
Incidence of abnormal physical examination findings
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Incidence of abnormal vital signs
+9 more

Side effects data

From 2022 Phase 4 trial • 353 Patients • NCT04041284
1%
COVID-19
1%
C-reactive protein increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-blind Phase: Placebo
Double-blind Phase: Fremanezumab
Open-label Phase: Placebo/Fremanezumab Dose 2
Open-label Phase: Fremanezumab Dose 1/Fremanezumab Dose 2

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FremanezumabExperimental Treatment1 Intervention
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fremanezumab
2016
Completed Phase 4
~5180

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,484,958 Total Patients Enrolled
8 Trials studying Migraine
5,377 Patients Enrolled for Migraine
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,361 Total Patients Enrolled
7 Trials studying Migraine
5,377 Patients Enrolled for Migraine

Media Library

Fremanezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04464707 — Phase 3
Migraine Research Study Groups: Fremanezumab, Placebo
Migraine Clinical Trial 2023: Fremanezumab Highlights & Side Effects. Trial Name: NCT04464707 — Phase 3
Fremanezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04464707 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT04464707 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new patients still sign up for this experiment?

"The clinical trial is still looking for patients, according to the most recent information available on clinicaltrials.gov. This page was originally published on 7/30/2020 and was last updated on 8/23/2022."

Answered by AI

In how many different medical institutions is this research being conducted today?

"Currently, there are 35 hospitals or research centres taking part in this clinical trial. For example, Teva Investigational Site 14370 in Loma Linda, Teva Investigational Site 14360 in Covington, and Teva Investigational Site 14273 in Austin."

Answered by AI

What was the Fremanezumab's most recent FDA decision?

"Given that this is a Phase 3 trial with supporting data for efficacy and safety, our team has estimated the safety of Fremanezumab to be a 3."

Answered by AI

Is this a new clinical trial?

"As of now, there are 4 ongoing studies for Fremanezumab that span 44 cities and 9 countries. The first study was done in 2020 by Teva Branded Pharmaceutical Products R&D, Inc. That initial Phase 3 trial had 288 participants and completed drug approval stages. In the two years since then, a total of 18292 studies have been conducted."

Answered by AI

Does this test include elderly patients in its demographic?

"The age range for this trial are individuals who have not yet reached their 18th birthday, but are older than 6 years old."

Answered by AI

Who can sign up for this medical study?

"This study is open to 418 participants, all of whom must be minors that have been diagnosed with migraines for over 6 months. Furthermore, these potential patients must also answer yes to the following questions: Have you experienced 8 migraines in the past month?, Have you experienced 15 headaches in the past month?, Are you applying as a caregiver on behalf of your child?"

Answered by AI

How many individuals are enrolled in this clinical trial?

"Yes, the clinical trial is recruiting participants at 35 sites across the United States. The trial was first posted on July 30th 2020 and was last updated on August 23rd 2022. A total of 418 patients are needed for the study."

Answered by AI

What other research has been published on Fremanezumab?

"There are 4 active clinical trials studying Fremanezumab, 3 of which have advanced to Phase 3. Although the majority of these trials are based in Dresden, Illinois, there are a total of 241 sites running these studies across the world."

Answered by AI

Who else is applying?

What state do they live in?
California
Virginia
Other
Tennessee
How old are they?
< 18
18 - 65
What site did they apply to?
Teva Investigational Site 14322
Teva Investigational Site 14374
Ascension Illinois Clinical Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

aspirin - Tylenol - Botox. Severe migraines and looking for treatment options.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do I have until I receive notification of study inclusion? What type of doctor is over seeing the medical condition of the treatment of the patient?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Teva Investigational Site 14263: < 48 hours
  2. Teva Investigational Site 14364: < 48 hours
Average response time
  • < 2 Days
~155 spots leftby Jun 2026