Verified

Fremanezumab for Migraine

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
MigraineFremanezumab - Drug
Eligibility
6 - 17
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Baseline, Month 1, and Month 3

Baseline - Month 3
Incidence of abnormal physical examination findings
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Incidence of abnormal vital signs
Mean change PedsQL after administration of the first dose of study drug
Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug
Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug
Mean change in the monthly average number of migraine days after the first dose of study drug
Number of adverse events
Number of participants developing antidrug antibodies (ADAs) throughout the study
Migraine Disorders
Baseline and Month 3
Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug
Month 3
Number of participants with clinically significant changes in laboratory values
Screening - Month 3
Yes/No suicidality ideation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Fremanezumab Quarterly
11%Injection site erythema
11%Nasopharyngitis
7%Injection site induration
5%Migraine
5%Injection site pain
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03308968) in the Fremanezumab Quarterly ARM group. Side effects include: Injection site erythema with 11%, Nasopharyngitis with 11%, Injection site induration with 7%, Migraine with 5%, Injection site pain with 5%.

Trial Design

2 Treatment Groups

Fremanezumab
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

288 Total Participants · 2 Treatment Groups

Primary Treatment: Fremanezumab · Has Placebo Group · Phase 3

Fremanezumab
Drug
Experimental Group · 1 Intervention: Fremanezumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fremanezumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 1, and month 3

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
244 Previous Clinical Trials
3,482,596 Total Patients Enrolled
8 Trials studying Migraine
5,588 Patients Enrolled for Migraine
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
87 Previous Clinical Trials
35,610 Total Patients Enrolled
7 Trials studying Migraine
5,588 Patients Enrolled for Migraine

Eligibility Criteria

Age 6 - 17 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Were you diagnosed with migraines more than 6 months ago?
Have you experienced 8 migraines in the past month?
Have you been using the same migraine medication for the past two months?
Have you experienced 15 headaches in the past month?
Are you applying as a caregiver on behalf of your child?

Who else is applying?

What state do they live in?
Virginia50.0%
California25.0%
Tennessee25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Teva Investigational Site 1432550.0%
Teva Investigational Site 1437450.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%