Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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

Key facts

Study ID

NCT02614196

Run by

Eli Lilly and Company

People needed

986

Starts

2015-12-04

Expected to finish

2018-10-05

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 migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (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 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 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
• Axiom Research — Apple Valley, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Optimus Medical Group — San Francisco, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• IMMUNOe International Research Centers — Centennial, Colorado, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Sunrise Clinical Research — Hollywood, Florida, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions Inc — Jacksonville, Florida, United States
• Sensible Healthcare — Ocoee, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Atlanta Center of Medical Research — Atlanta, Georgia, United States
• Christie Clinic, LLC — Champaign, Illinois, United States
• Diamond Headache Clinic — Chicago, Illinois, United States
• Josephson Wallack Munshower Neurology — Indianapolis, Indiana, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Novex Clinical Research — New Bedford, Massachusetts, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Healthcare Research Network - Hazelwood — Hazelwood, Missouri, United States
• Nevada Headache Institute — Las Vegas, Nevada, United States
• 21st Century Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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