Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Fremanezumab; Placebo
Intervention description: Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration.
The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.; Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.
Intervention MeSH terms: Calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 875.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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

Eligibility 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 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