Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo; Erenumab PFS; Erenumab AI/Pen
Intervention description: Administered by study site staff once a month (QM) as a subcutaneous injection; Administered by study site staff once a month (QM) as a subcutaneous injection; Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy; Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
Intervention MeSH terms: Erenumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the DBTP participants were randomized to one of four arms. In the optional CHU substudy participants were randomized into one of two treatment groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 483.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: migraine, headache, prevention, prophylaxis

Summary:

      A study to evaluate the effect of erenumab compared to placebo on the change from baseline in
      monthly migraine days in participants with episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of migraine for more than12 months prior to screening

          -  Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior
             to screening and during baseline phase

          -  Headache frequency: < 15 headache days per month (with > 50% of the headache days
             being migraine days) in each of the 3 months prior to screening and during baseline
             phase

          -  Demonstrated at least 80% compliance with the eDiary during baseline phase

        Exclusion Criteria:

          -  Older than 50 years of age at migraine onset

          -  History of cluster headache or basilar or hemiplegic migraine headache

          -  Unable to differentiate migraine from other headaches

          -  No therapeutic response with > 2 of the following eight medication categories for
             prophylactic treatment of migraine after an adequate therapeutic trial. Medication
             categories are:

               -  Category 1: Divalproex sodium, sodium valproate

               -  Category 2: Topiramate

               -  Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol,
                  nadolol, nebivolol, pindolol, propranolol, timolol)

               -  Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline,
                  protriptyline)

               -  Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran

               -  Category 6: Flunarizine, verapamil

               -  Category 7: Lisinopril, candesartan

               -  Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100
                  mg/day)

          -  Overuse of acute migraine medications in any month during the 3 months prior to
             screening or during screening