A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

Plain-language summary

This study evaluates the safety of the drug Galcanezumab in patients with migraine, with or without aura. Patients with at least a one-year history of episodic or chronic migraine who have averaged 4 or more migraine days per month over the past 3 months 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

Start date

11/30/2015

Estimated completion

8/14/2018

Countries

United States, Belgium, Canada, France, Hungary, Puerto Rico

Related genes

Locations

• Santa Monica, United States
• Spring Valley, United States
• Stamford, United States
• Hollywood, United States
• Jacksonville, United States
• St Louis, United States
• Albuquerque, United States
• Greensboro, United States
• Wilmington, United States
• Media, United States
• Waxahachie, United States
• Clinton, United States
• Roanoke, United States
• Bruges, Belgium
• Brussels, Belgium
• Liège, Belgium
• Calgary, Canada
• Sherbrooke, Canada
• Toronto, Canada
• Marseille, France
• Nice, France
• Paris, France
• Saint-Etienne, France
• Budapest, Hungary
• Esztergom, Hungary
• Győr, Hungary
• Ponce, Puerto Rico

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 or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 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.
* Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.

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.