A Multicenter Assessment of ALD403 in Frequent Episodic Migraine



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:9/26/2018
Start Date:September 2015
End Date:December 2017

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A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines

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


Inclusion Criteria:

- Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

- History of migraine ≥ 12 months with

- ≤ 14 headache days of which at least 4 have to be migraine days (migraine days
count as headache days) in each 28 day period in the 3 months prior to screening

- During the 28 days following the screening visit, the subject experiences ≤ 14
headache days of which at least 4 have to be migraine days (migraine days count
as headache days) as recorded in the eDiary

- No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons
requiring injections in the head, face, or neck 4 months prior to screening and during
the 28 day period prior to randomization

- Headache eDiary was completed on at least 25 of the 28 days prior to randomization

Exclusion Criteria:

- Confounding pain syndromes, e.g. fibromyalgia, 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- II, 2004 Section 1), 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

- 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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