A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine
Migraine
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- The participant has a diagnosis of migraine with onset at ≤50 years of age.
- The participant has a body weight ≥45 kg and body mass index within the range 17.5 to 34.9 kg/m2 (inclusive).
- 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 for 6.0 months after discontinuation of investigational medicinal product (IMP).
- Men must be sterile or, if they are potentially fertile/reproductively competent (not congenitally sterile) and their female partners are of childbearing potential, should use highly effective birth control for the duration of the study.
- Additional criteria apply, please contact the investigator for more information.
Exclusion Criteria:
- Use of medications containing opioids (including codeine), barbiturates (including butalbital), or any combination product containing opioids or barbiturates (including butalbital) on more than 4 days during the screening period for the treatment of migraine or for any other reason.
- Has used an intervention/device (eg, scheduled nerve blocks or transcranial magnetic stimulation) for migraine, or in the head or neck area, during the 2 months prior to screening (visit 1).
- History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], or peripheral extremity ischemia or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.
- History of human immunodeficiency virus, tuberculosis, Lyme disease, or hepatitis B or C virus, or a known or suspected active infection of coronavirus disease 2019 (COVID-19).
- History of cancer in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.
- History of hypersensitivity reactions to injected proteins, including monoclonal antibodies (mAbs), or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or is concomitantly using lamotrigine.
- Any clinically significant uncontrolled medical condition (treated or untreated).
- History of alcohol or drug abuse during the past 2 years or drug dependence during the past 5 years.
- Additional criteria apply, please contact the investigator for more information.
Sites / Locations
- Teva Investigational Site 88004Recruiting
- Teva Investigational Site 88001Recruiting
- Teva Investigational Site 88019Recruiting
- Teva Investigational Site 88020Recruiting
- Teva Investigational Site 88031Recruiting
- Teva Investigational Site 88013Recruiting
- Teva Investigational Site 88011Recruiting
- Teva Investigational Site 88026Recruiting
- Teva Investigational Site 88005Recruiting
- Teva Investigational Site 88030Recruiting
- Teva Investigational Site 88015Recruiting
- Teva Investigational Site 88008Recruiting
- Teva Investigational Site 88009Recruiting
- Teva Investigational Site 88032Recruiting
- Teva Investigational Site 88021Recruiting
- Teva Investigational Site 88025Recruiting
- Teva Investigational Site 88003Recruiting
- Teva Investigational Site 88033Recruiting
- Teva Investigational Site 88024Recruiting
- Teva Investigational Site 88023Recruiting
- Teva Investigational Site 88017Recruiting
- Teva Investigational Site 88028Recruiting
- Teva Investigational Site 88029Recruiting
- Teva Investigational Site 88010Recruiting
- Teva Investigational Site 88012Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Fremanezumab Monthly
Fremanezumab Quarterly
Placebo
Double Blind (DB) Period: Participants will receive fremanezumab once a month (approximately every 4 weeks). Participants will receive a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57. Open Label (OL) Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
DB Period: Participants will receive fremanezumab once a quarter (once at the beginning of the 12-week double-blind treatment period). Participants will receive 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57. OL Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
DB Period: Participants will receive placebo once a month (approximately every 4 weeks). Participants will receive 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57. OL Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.