A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

Amgen

Status and phase: Completed; Phase 2

Conditions: Treatment for Prevention of Chronic Migraine

Treatments: Drug: Placebo; Biological: Erenumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066415

20120295

2013-001707-36 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 667 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
• History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
• ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
• Demonstrated at least 80% compliance with the eDiary.

Exclusion criteria

• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headaches
• Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
• Received botulinum toxinin head or neck region within 4 months prior to screening.
• Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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667 participants in 3 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.

Treatment:

Drug: Placebo

Erenumab 70 mg

Experimental group

Description:

Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.

Treatment:

Biological: Erenumab

Erenumab 140 mg

Placebo Comparator group

Description:

Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.

Treatment:

Biological: Erenumab