A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

Key facts

Study ID

NCT03559257

Run by

Eli Lilly and Company

People needed

463

Starts

2018-07-31

Expected to finish

2019-09-19

Last updated by the study team

2020-07-08

Who can join

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

You may qualify if…

• Have a diagnosis of migraine or chronic migraine.
• History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.
• History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.
• Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.

You may not qualify if…

• Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
• Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
• History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine).
• Pregnant or nursing.

Where it is running

• Medical Center for Clinical Research — San Diego, California, United States
• Sensible Healthcare — Ocoee, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Renstar Medical Research — Wesley Chapel, Florida, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Michigan Head, Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• Healthy Perspectives Innovative Mental Health Services, PL — Nashua, New Hampshire, United States
• Bio Behavioral Health — Toms River, New Jersey, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• PharmQuest — Greensboro, North Carolina, United States
• Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States
• Coastal Carolina Research Center, Inc. — Mt. Pleasant, South Carolina, United States
• Foothill Family Clinic — Salt Lake City, Utah, United States
• Health Research of Hampton Roads Inc — Newport News, Virginia, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Algemeen Ziekenhuis St Jan Brugge — Bruges, Belgium
• Universitair Ziekenhuis Brussel — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Okanagan Clinical Trials — Kelowna, British Columbia, Canada
• Aggarwal and Associates Ltd — Brampton, Ontario, Canada
• DIEX Recherche Sherbrooke, Inc — Sherbrooke, Quebec, Canada
• Clintrial, s.r.o. — Prague, Hl. M. Praha, Czechia
• 21st Century Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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