A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine
Inclusion Criteria:
Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age
Patient signs and dates the informed consent document
Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis
85% e-diary compliance
Total body weight between 99 and 250 lbs, inclusive
Exclusion Criteria:
Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], 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
Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma
Pregnant or nursing females
History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer
Chofu-shi, 182-0006, Japan
Chofu-shi, Japan
Chofu-shi, Japan
Kawasaki-shi, Japan
Saitama-shi, Japan
Toyonaka-shi, Japan