Status:
COMPLETED
A Multicenter Assessment of ALD403 in Chronic Migraine
Lead Sponsor:
Alder Biopharmaceuticals, Inc.
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
665 Patients enrolled
Trial Details
Trial ID
NCT02275117
Start Date
October 1 2014
End Date
November 1 2016
Last Update
April 8 2020
Active Locations (92)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Mobile, Alabama, United States, 36608
3
Research Site
Phoenix, Arizona, United States, 85027
4
Research Site
Scottsdale, Arizona, United States, 85259