An Efficacy and Safety Study of Fremanezumab in Adults With Migraine
Condition: Migraine Prophylaxis
MeSH terms: Migraine Disorders
Intervention: Fremanezumab; Placebo
Intervention description: Fremanezumab will be administered per dose and schedule specified in the arm.; Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 838.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly
      and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of
      placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have
      responded inadequately to 2 to 4 classes of prior preventive treatments.

      Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in
      blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1
      placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all
      participants continue into an open-label extension of 3 months (up to Week 24) during which
      everyone is administered sc injections of fremanezumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has a diagnosis of migraine with onset at ≤50 years of age.

          -  Body weight ≥45 kilograms.

          -  The participant has a history of migraine for ≥12 months prior to screening.

          -  Women of childbearing potential (WOCBP) whose male partners are potentially fertile
             (that is; no vasectomy) must use highly effective birth control methods for the
             duration of the study and the follow-up period and for 6.0 months after
             discontinuation of investigational medicinal product (IMP)

          -  Men must be sterile, or if they are potentially fertile/reproductively competent (not
             surgically [that is; vasectomy] or congenitally sterile) and their female partners are
             of childbearing potential, must use, together with their female partners, acceptable
             birth control methods for the duration of the study and for 6.0 months after
             discontinuation of the investigational medicinal product (IMP).

               -  Additional criteria apply, please contact the investigator for more information.

        Exclusion Criteria:

          -  At the time of screening visit, participant is receiving any preventive migraine
             medications, regardless of the medical indication for more than 5 days and expects to
             continue with these medications.

          -  Participant has received onabotulinumtoxinA for migraine or for any medical or
             cosmetic reasons requiring injections in the head, face, or neck during the 3 months
             before screening visit.

          -  The participant has used an intervention/device (for example; scheduled nerve blocks
             and transcranial magnetic stimulation) for migraine during the 2 months prior to
             screening.

          -  The participant uses triptans/ergots as preventive therapies for migraine.

          -  Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy
             for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for
             example; 81 mg) used for cardiovascular disease prevention is allowed.

               -  Additional criteria apply, please contact the investigator for more information.