A Multicenter Assessment of ALD403 in Chronic Migraine



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:9/26/2018
Start Date:October 2014
End Date:November 2016

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A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine

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


Inclusion Criteria:

- Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year

- During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days
were assessed as migraine days with at least 5 migraine attacks as recorded in the
eDiary

- Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Exclusion Criteria:

- Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional
pain syndrome) or any pain syndrome that requires regular analgesia

- Psychiatric conditions that are uncontrolled and untreated, including conditions that
are not controlled for a minimum of 6 months prior to screening.

- History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic
tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
daily persistent headache, migraine with brainstem aura, sporadic and familial
hemiplegic migraine

- Unable to differentiate migraine from other headaches

- Subject has received botulinum toxin for migraine or for any other medical/cosmetic
reasons requiring injections in the head, face, or neck within 4 months prior to
screening.

- Have any clinically significant concurrent medical condition

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

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