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Monoclonal Antibodies

Fremanezumab for Preventing Migraines

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 been using the same migraine medication for the past two months?
Have you experienced 8 migraines in the past month?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 1, and month 3
Awards & highlights

Study Summary

This trial is designed to see if the drug fremanezumab is effective in preventing migraines. It will last up to 36 months and will compare the drug to a placebo.

Who is the study for?
This trial is for children aged 6 to 17 who have been diagnosed with episodic migraines for over six months, experiencing at least 8 migraines and a total of 15 headaches in the past month. They should be on stable migraine medication for two months.Check my eligibility
What is being tested?
The study tests if Fremanezumab is more effective than a placebo in preventing episodic migraines in young patients. It's designed to compare outcomes between the drug and placebo over up to three years, also assessing safety and immune response.See study design
What are the potential side effects?
While not specified here, common side effects of Fremanezumab may include injection site reactions (pain or redness), itching, rash, muscle pain, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been taking the same medication for your migraines for the past two months.
Select...
I have experienced 8 migraines in the past month.
Select...
I was diagnosed with migraines over 6 months ago.
Select...
I have had 15 headaches in the past month.
Select...
I am applying for my child as their 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 migraine days 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%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Phase: Fremanezumab Dose 1/Fremanezumab Dose 2
Double-blind Phase: Placebo
Double-blind Phase: Fremanezumab
Open-label Phase: Placebo/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
249 Previous Clinical Trials
3,484,877 Total Patients Enrolled
8 Trials studying Migraine
5,507 Patients Enrolled for Migraine
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
91 Previous Clinical Trials
38,272 Total Patients Enrolled
7 Trials studying Migraine
5,507 Patients Enrolled for Migraine

Media Library

Fremanezumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04458857 — Phase 3
Migraine Research Study Groups: Fremanezumab, Placebo
Migraine Clinical Trial 2023: Fremanezumab Highlights & Side Effects. Trial Name: NCT04458857 — Phase 3
Fremanezumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04458857 — Phase 3
Migraine Patient Testimony for trial: Trial Name: NCT04458857 — Phase 3

Frequently Asked Questions

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

Has the United States Federal Drug Administration given their okay to Fremanezumab?

"There is supporting clinical data for Fremanezumab's efficacy and safety, so it received a score of 3."

Answered by AI

How can I become a candidate for this research project?

"According to the eligibility requirements, candidates must suffer from migraines, be between 6 and 17 years old, and not have any other conflicting medical conditions. A total of 288 participants can enroll in the trial."

Answered by AI

Are there other ongoing or completed investigations involving Fremanezumab?

"4 clinical trials for Fremanezumab are still live, with 3 of them in Phase 3. Most of these trials originated in Dresden, Illinois; however, there are now 241 active locations for these trials."

Answered by AI

How many total individuals are taking part in this experiment?

"The clinical trial will require 288 participants that satisfy the pre-determined inclusion criteria. The sponsor, Teva Branded Pharmaceutical Products R&D, Inc., will manage the study from various locations, two of which are Teva Investigational Site 14365 in Baltimore, Maryland and Teva Investigational Site 14277 in Tacoma, Washington."

Answered by AI

What is the precedent for this type of research?

"First studied in 2020, Fremanezumab is still being researched today by Teva Branded Pharmaceutical Products R&D, Inc. and others. There are 4 clinical trials currently underway across 9 countries and 44 cities."

Answered by AI

Are there any positions still available for participants in this research?

"Yes, this information is correct. The study is still recruiting patients and the most recent update was on 8/23/2022."

Answered by AI

Does this research study have an age limit?

"As this is a clinical trial for children and adolescents, only patients aged 6 to 17 are eligible to apply. Out of the 356 total clinical trials, 35 studies focus on this age group while 121 are for patients over 65 years old."

Answered by AI

Are there different research facilities within the state that are conducting this investigation?

"There are a total of 35 medical centres enrolling patients in this trial, including Teva Investigational Site 14365 in Baltimore, Teva Investigational Site 14277 in Tacoma, and Teva Investigational Site 14325 in Miami."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
Virginia
Tennessee
Other
How old are they?
18 - 65
What site did they apply to?
Teva Investigational Site 14325
Teva Investigational Site 14250
Teva Investigational Site 14374
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?

Looking for better migraine relief. I have headaches everyday and migraines half of a month.
PatientReceived no prior treatments
I have to take fiorocet to get any relief from these stupid headaches.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Teva Investigational Site 14250: < 48 hours
Average response time
  • < 2 Days
~62 spots leftby Mar 2025