Status:
COMPLETED
An Efficacy and Safety Study of Fremanezumab in Adults With Migraine
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Migraine Prophylaxis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in particip...
Eligibility Criteria
Inclusion
- The participant has a diagnosis of migraine with onset at ≤50 years of age.
- Body weight ≥45 kilograms.
- The participant has a history of migraine for ≥12 months prior to screening.
- Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP)
- Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically \[that is; vasectomy\] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP).
- Additional criteria apply, please contact the investigator for more information.
Exclusion
- At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.
- Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.
- The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.
- The participant uses triptans/ergots as preventive therapies for migraine.
- Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed.
- Additional criteria apply, please contact the investigator for more information.
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2019
Estimated Enrollment :
838 Patients enrolled
Trial Details
Trial ID
NCT03308968
Start Date
October 13 2017
End Date
May 29 2019
Last Update
November 9 2021
Active Locations (113)
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1
Teva Investigational Site 14742
Huntsville, Alabama, United States, 35801
2
Teva Investigational Site 14729
Long Beach, California, United States, 90806
3
Teva Investigational Site 14739
San Diego, California, United States, 92103
4
Teva Investigational Site 14843
Santa Monica, California, United States, 90404