A Multicenter Assessment of ALD403 in Chronic Migraine

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine Disorders

In brief

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

Key facts

Study ID

NCT02275117

Run by

Alder Biopharmaceuticals, Inc.

People needed

665

Starts

2014-10-01

Expected to finish

2016-11-01

Last updated by the study team

2020-04-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Mobile, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Hot Springs, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Encino, California, United States
• Reserach Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Oakland, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Stanford, California, United States
• Research Site — Ventura, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Hallandale, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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