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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:6/23/2018
Start Date:March 5, 2014
End Date:April 28, 2016

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A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention

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.

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).

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
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35
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Greensboro, North Carolina 27401
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Indianapolis, IN
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Palm Beach Gardens, Florida 33410
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