An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine

Completed · Phase 3

Conditions studied: Migraine Disorder

In brief

An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine

Key facts

Study ID

NCT02985398

Run by

Alder Biopharmaceuticals, Inc.

People needed

128

Starts

2016-12-01

Expected to finish

2019-03-01

Last updated by the study team

2020-04-21

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.

You may not qualify if…

• Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
• 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.
• 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.

Where it is running

• Research Site — San Diego, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Bradenton, Florida, United States
• Research Site — DeLand, Florida, United States
• Massachusetts — Miami, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Haven, Florida, United States
• Research Site — Prairie Village, Kansas, United States
• Massachusetts — Boston, Massachusetts, United States
• Research Site — North Attleboro, Massachusetts, United States
• 02481 — Wellesley, Massachusetts, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Mt. Pleasant, South Carolina, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Fort Worth, Texas, United States
• Research Site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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