Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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

Key facts

Study ID

NCT02614183

Run by

Eli Lilly and Company

People needed

862

Starts

2015-11-30

Expected to finish

2018-08-09

Last updated by the study team

2020-06-17

Who can join

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

You may qualify if…

• Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine Headache Days (MHD).

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 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

• Orange Grove Family Practice — Tucson, Arizona, United States
• Arkansas Clinical Research — Little Rock, Arkansas, United States
• Advanced Clinical Research — Carmichael, California, United States
• Pharmacology Research Institute, Newport Beach — Encino, California, United States
• Tooraj Joseph Raoof M.D., Inc. — Encino, California, United States
• Fullerton Neurology and Headache Center — Fullerton, California, United States
• Sun Valley Research Center — Imperial, California, United States
• Irvine Clinical Research Center — Irvine, California, United States
• Pharmacology Research Institute, Newport Beach — 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
• Alpine Clinical Research Center — Boulder, Colorado, United States
• MCB Clinical Research Centers — Colorado Springs, Colorado, United States
• Mile High Research Center — Denver, Colorado, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Advanced Neurosciences Research, LLC — Fort Collins, Colorado, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Meridien Research — Bradenton, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Territory Neurology & Research Institute — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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