Conditions: Migraine
Keywords: Migraine Headache Episodic Prevention Prophylaxis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 577
Healthy volunteers: no

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

Detailed description:
Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to \< 15 migraine days per month with \< 15 headache days per month will be randomized 1:1 to placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.

Arms:
arm 1: Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase. arm 2: Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase.

Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered once a month by subcutaneous injection intervention 2: Administered once a month by subcutaneous injection

Protocol document: