Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:9/21/2018
Start Date:November 2016
End Date:April 2018

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A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine

The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of
migraine headache in chronic migraineurs.


Inclusion Criteria:

- Males and females between 18 and 65 years of age, inclusive, who were diagnosed with
migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months
before screening.

- During the 28 day screening period, subjects must adequately complete the headache
eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must
be migraine days.

- Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

Exclusion Criteria:

- Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low
back pain, complex regional pain syndrome).

- Psychiatric conditions that are uncontrolled and/or untreated, including conditions
that are not controlled for a minimum of 6 months prior to screening. Patients with a
lifetime history of psychosis, mania, or dementia are excluded.

- Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons
requiring injections within 4 months prior to screening and during the screening
period.

- History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic
tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
daily persistent headache, or sporadic and familial hemiplegic migraine.

- Receipt of any monoclonal antibody treatment (within or outside a clinical trial)
within 6 months before screening.

- Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
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