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Monoclonal Antibodies

Fremanezumab for Migraine

Q: 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.

Q: How can I become a candidate for this research project?

According to the eligibility requirements, candidates must suffer from <a href="https://www.withpower.com/clinical-trials/migraine">migraine</a>s, 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.

Q: 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.

Q: 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&#x26;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.

Q: 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&#x26;D, Inc. and others. There are 4 clinical trials currently underway across 9 countries and 44 cities.

Q: 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.

Q: 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.

Q: 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.

Teva Investigational Site 80169, Jerusalem, Israel

Fremanezumab +1 morePhase 3RecruitingResearch 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

Were you diagnosed with migraines more than 6 months ago?

Have you experienced 8 migraines in the past month?

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline, month 1, and month 3

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

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.

Eligible Conditions

Migraine

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have been diagnosed with migraines for at least 6 months.

Select...

You have had 8 or more migraines in the last month.

Select...

You have been taking the same medication for your migraines for the past two months.

Select...

Are you applying to participate in the study as a parent or guardian of a child?

Select...

You have had 15 or more headaches in the past month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1, and month 3

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 2019 Phase 3 trial • 838 Patients • NCT03308968

11%

Injection site erythema

11%

Nasopharyngitis

Injection site induration

Injection site pain

Migraine

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fremanezumab Quarterly

Fremanezumab Monthly

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

FDA approved

0 / 5Eligibility criteria met

Find a site

Who is running the clinical trial?

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

246 Previous Clinical Trials

3,482,657 Total Patients Enrolled

8 Trials studying Migraine

5,588 Patients Enrolled for Migraine

Teva Medical Expert, MDStudy Director

Teva Branded Pharmaceutical Products R&D, Inc.

87 Previous Clinical Trials

35,614 Total Patients Enrolled

7 Trials studying Migraine

5,588 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