Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders

In brief

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

Key facts

Study ID

NCT02974153

Run by

Alder Biopharmaceuticals, Inc.

People needed

1121

Starts

2016-11-01

Expected to finish

2018-04-01

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
• During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days.
• Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

You may not qualify if…

• Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
• Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
• Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
• History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
• Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
• Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Carlsbad, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Orange, California, United States
• Research Site — Oxnard, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — Redlands, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Torrance, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — New London, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Winter Haven, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Champaign, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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