A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

Completed · Phase 3 · 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 frequent episodic migraineurs.

Key facts

Study ID

NCT02559895

Run by

Alder Biopharmaceuticals, Inc.

People needed

898

Starts

2015-09-01

Expected to finish

2017-12-01

Last updated by the study team

2020-05-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Fresno, California, United States
• Research Site — Fullerton, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Montclair, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Redlands, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Sherman Oaks, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Fort Collins, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Bradenton, Florida, United States
• Research Site — DeLand, Florida, United States
• Research site — Fort Myers, Florida, United States
• Research Site — Hallandale, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Maitland, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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