← Back to Search

Monoclonal Antibodies

Fremanezumab for Migraine

Phase 4
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 8, 12, and 24
Awards & highlights

Study Summary

This trial is evaluating the efficacy of fremanezumab in adult patients with migraine and major depressive disorder. The objectives are to assess the reduction of MDD symptoms, responder rates in monthly migraine days, improving quality of life, improving disability, and the safety and tolerability of monthly 225 mg sc and quarterly 675 mg sc fremanezumab.

Eligible Conditions
  • Depression
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 12, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 8, 12, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week DB Treatment Phase After the First Dose of Study Drug
Secondary outcome measures
Change From Baseline in 6-Item Headache Impact Test (HIT-6) Disability Score at Week 12
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Scale Score at Weeks 4, 8, and 12
Change From Baseline in Hamilton Depression Rating Scale-17 (HAM-D 17) Items Total Score at Week 8
+10 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
monthly 225 mg. In the open-label extension phase starting at week 12, all participants will receive active treatment with a quarterly dose of 675 mg sc
Group II: PlaceboPlacebo Group1 Intervention
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
3,485,023 Total Patients Enrolled
8 Trials studying Migraine
5,442 Patients Enrolled for Migraine
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,418 Total Patients Enrolled
7 Trials studying Migraine
5,442 Patients Enrolled for Migraine

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
South Carolina
Indiana
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder
2019. "A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04041284.
~63 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top