Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic 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 265 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 or 5 half-lives, whichever is longer

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