Conditions: Treatment for Prevention of Chronic Migraine
Keywords: Chronic Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 667
Healthy volunteers: no

Brief summary:
To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

Detailed description:
This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy.

Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).

Arms:
arm 1: Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection. arm 2: Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. arm 3: Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.

Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered once a month subcutaneously by authorized investigational site study staff. intervention 2: Administered once a month subcutaneously by authorized investigational site study staff.

Protocol document: