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

Plain-language summary

This study evaluates 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

11/30/2015

Estimated completion

8/9/2018

Countries

United States, Canada, Puerto Rico

Related genes

Locations

• Tucson, United States
• Tucson, United States
• Little Rock, United States
• Carmichael, United States
• Encino, United States
• Encino, United States
• Fullerton, United States
• Imperial, United States
• Irvine, United States
• Los Alamitos, United States
• Newport Beach, United States
• Rancho Mirage, United States
• Redlands, United States
• San Diego, United States
• San Diego, United States
• Boulder, United States
• Colorado Springs, United States
• Denver, United States
• Englewood, United States
• Fort Collins, United States
• Waterbury, United States
• Bradenton, United States
• Gainesville, United States
• New Port Richey, United States
• Ocala, United States
• Ocoee, United States
• Orlando, United States
• Oviedo, United States
• Port Orange, United States
• Sarasota, United States
• Sunrise, United States
• West Palm Beach, United States
• Meridian, United States
• Blue Island, United States
• Anderson, United States
• Elwood, United States
• Indianapolis, United States
• Newburgh, United States
• West Des Moines, United States
• Prairie Village, 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 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).

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 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.