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

Plain-language summary

This study evaluates the efficacy and safety of the drug Galcanezumab, compared with placebo, for the prevention of migraine attacks in patients with episodic migraine. Patients with at least a one-year history of migraine who experience 4 to 14 migraine days per month may take part. The study was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Eli Lilly and Company

Intervention

Galcanezumab, Placebo

Start date

12/4/2015

Estimated completion

10/5/2018

Countries

United States, Argentina, Czechia, Germany, Israel, Mexico, Netherlands, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom

Related genes

Locations

• Phoenix, United States
• Phoenix, United States
• Apple Valley, United States
• Los Angeles, United States
• Montclair, United States
• Oakland, United States
• San Diego, United States
• San Francisco, United States
• Sherman Oaks, United States
• Centennial, United States
• Coral Gables, United States
• Hollywood, United States
• Jacksonville, United States
• Jacksonville, United States
• Ocoee, United States
• Tampa, United States
• Atlanta, United States
• Champaign, United States
• Chicago, United States
• Indianapolis, United States
• Wichita, United States
• New Bedford, United States
• Farmington Hills, United States
• Hazelwood, United States
• Las Vegas, United States
• Toms River, United States
• Albuquerque, United States
• Binghamton, United States
• Brooklyn, United States
• High Point, United States
• Akron, United States
• Cincinnati, United States
• Columbus, United States
• Dayton, United States
• Oklahoma City, United States
• Springfield, United States
• Philadelphia, United States
• Greer, United States
• Mt. Pleasant, United States
• Dallas, United States

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.