Evaluation of Galcanezumab in the Prevention of Chronic Migraine

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.

Key facts

Study ID

NCT02614261

Run by

Eli Lilly and Company

People needed

1117

Starts

2015-11-30

Expected to finish

2021-07-14

Last updated by the study team

2022-05-18

Who can join

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

You may qualify if…

• Main Study:
• Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
• Israel addendum:
• Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
• Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.

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.
• Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
• 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) defined by IHS ICHD-3 beta.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Pharmacology Research Institute, Encino — Encino, California, United States
• Fullerton Neurology and Headache Center — Fullerton, California, United States
• Pharmacology Research Institute, Los Alamitos — Los Alamitos, California, United States
• Pharmacology Research Institute, Newport Beach — Newport Beach, California, United States
• Desert Valley Research — Rancho Mirage, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Optimus Medical Group — San Francisco, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Advanced Neurosciences Research, LLC — Fort Collins, Colorado, United States
• Associated Neurologists of Southern Connecticut — Fairfield, Connecticut, United States
• Avail Clinical Research LLC — DeLand, Florida, United States
• Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
• |Renstar Medical Research — Ocala, Florida, United States
• Psychiatric Inst of Florida-Clinical Neuroscience Solutions — Orlando, Florida, United States
• Compass Research — Oviedo, Florida, United States
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Christie Clinic, LLC — Champaign, Illinois, United States
• Robbins Headache Clinic — Riverwoods, Illinois, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Phoenix Medical Research, Inc — Prairie Village, Kansas, United States
• 21st Century Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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