Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Fremanezumab; Placebo
Intervention description: Fremanezumab will be administered as per the dose and schedule specified in the respective arms.; Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1890.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC)
      administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic
      migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of
      TEV-48125 (TV48125-CNS-30049 [NCT02621931] and TV48125-CNS-30050 [NCT02629861]) and agree to
      participate in this study; and new participants meeting eligibility criteria (not rolling
      over from pivotal studies), will be enrolled in this study.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants Rolling Over from the Pivotal Efficacy Studies:

          -  Participant must have signed and dated the informed consent document.

          -  Participant must have completed the pivotal efficacy study without major protocol
             violations.

               -  Additional criteria apply, please contact the investigator for more information.

        Participants Not Rolling Over from the Pivotal Efficacy Studies:

          -  Males or females aged 18 to 70 years, inclusive, with migraine onset at less than or
             equal to (≤) 50 years of age.

          -  Participant signed and dated the informed consent document.

          -  Participant has a history of migraine or clinical judgment suggests a migraine
             diagnosis.

          -  Participant fulfills the criteria for EM or CM with prospectively collected baseline
             information during the 28-day run-in period.

          -  Body mass index (BMI) of 17.5 to 37.5 kilograms/square meter (kg/m^2) and a total body
             weight between 45 and 120 kg, inclusive.

          -  All participants must be of non-childbearing potential.

               1. Participants must simultaneously use 2 forms of highly effective contraception
                  methods.

               2. Participants will remain abstinent throughout the study.

          -  Female participants of childbearing potential must have a negative serum beta-human
             chorionic gonadotropin (β-HCG) pregnancy test prior at screening (confirmed by urine
             dipstick β-HCG pregnancy test at baseline).

          -  The participant must be willing and able to comply with study restrictions, to remain
             at the clinic for the required duration during the study period, and to return to the
             clinic for the follow-up evaluation.

               -  Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

        Participants Rolling Over from the Pivotal Efficacy Studies:

          -  Pregnant or nursing females

          -  Compliance with daily diary entry lower than 75 percent (%) at the last month of the
             double-blind treatment period of the pivotal efficacy study.

               -  Additional criteria apply, please contact the investigator for more information.

        Participants Not Rolling Over from the Pivotal Efficacy Studies:

          -  Clinically significant findings 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 [for example; 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 past 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 before study drug administration or 5 half-lives, whichever is longer.

          -  History of alcohol or drug abuse during the past 2 years, or alcohol or drug
             dependence during the past 5 years.

          -  The participant cannot participate or successfully complete the study, in the opinion
             of their healthcare provider or the investigator, for any of the following reasons:

               1. mentally or legally incapacitated or unable to give consent for any reason.

               2. in custody due to an administrative or a legal decision, under guardianship, or
                  institutionalized.

               3. unable to be contacted in case of emergency.

               4. has any other condition, which, in the opinion of the investigator, makes the
                  participant inappropriate for inclusion in the study.

          -  Participant is a study center or sponsor employee who is directly involved in the
             study or the relative of such an employee.

               -  Additional criteria apply, please contact the investigator for more information.