A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine

Plain-language summary

This study evaluates the drug Galcanezumab compared with placebo in Japanese patients with episodic migraine. It enrolled adults with at least a one-year history of migraine that began before age 50. It was conducted in Phase 2 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 2

Status

Completed

Sponsor

Eli Lilly and Company

Intervention

Galcanezumab, Placebo

Start date

11/9/2016

Estimated completion

1/18/2019

Countries

Japan

Related genes

Locations

• Chiba, Japan
• Chofu-shi, Japan
• Fukui, Japan
• Fukui, Japan
• Fukuoka, Japan
• Higashioka, Japan
• Hiroshima, Japan
• Iruma-Gun, Japan
• Kagoshima, Japan
• Kasaoka-shi, Japan
• Kawasaki, Japan
• Kawasaki, Japan
• Kobe, Japan
• Kobe, Japan
• Kochi, Japan
• Kōchi, Japan
• Kyoto, Japan
• Kyoto, Japan
• Matsuyama, Japan
• Matsuyama, Japan
• Minatoku, Japan
• Minatoku, Japan
• Morioka, Japan
• Morioka, Japan
• Morioka, Japan
• Niigata, Japan
• Nishinomiya, Japan
• Nishinomiya, Japan
• Nishinomiya, Japan
• Okayama, Japan
• Osaka, Japan
• Ota-shi, Japan
• Ōita, Japan
• Saijo-shi, Japan
• Saitama, Japan
• Sapporo, Japan
• Sapporo, Japan
• Sendai, Japan
• Shibuya-ku, Japan
• Shinjuku-ku, Japan

+7

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 guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

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 other antibodies to CGRP or its receptor.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
* 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.