Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention (ARISE)

Amgen

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Erenumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02483585

20120297

2014-004463-20 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 577 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of migraines (with or without aura) for ≥ 12 months
• Migraine frequency: ≥ 4 and < 15 migraine days per month on average acrossthe 3 months prior to screening
• Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening
• Demonstrated compliance with the eDiary

Exclusion criteria

• Older than 50 years of age at migraine onset.
• History of cluster headache or hemiplegic migraine headache.
• Unable to differentiate migraine from other headaches
• No therapeutic response with > 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
• Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
• Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase.
• Received botulinum toxin
• Anticipated to require any excluded medication, device, or procedure during the study.
• Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).
• History of major psychiatric disorder.
• History of seizure disorder or other significant neurological conditions other than migraine.
• Human immunodeficiency virus (HIV) infection by history.
• Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening.
• The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study.
• Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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577 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Erenumab

Experimental group

Description:

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.

Treatment:

Drug: Erenumab