Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

• Status: Completed
• Trial end date: 2017-04-11
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Calcitonin; Calcitonin Gene-Related Peptide; Immunoglobulins; Katacalcin

Criteria

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

• Additional criteria apply, please contact the investigator for more information

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

• Additional criteria apply, please contact the investigator for more information