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

Plain-language summary

This study evaluates the drug Galcanezumab in Japanese patients with migraine, including chronic migraine. It enrolled adults with at least a one-year history of migraine who had a diagnosis of chronic migraine or had completed the earlier episodic migraine study. It 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

2/7/2017

Estimated completion

8/10/2019

Countries

Japan

Related genes

Locations

• Chofu-shi, Japan
• Fukui, Japan
• Fukuoka, Japan
• Higashiosaka, Japan
• Hiroshima, Japan
• Ibaraki, Japan
• Iruma-Gun, Japan
• Kagawa, Japan
• Kagoshima, Japan
• Kagoshima, Japan
• Kaisho, Japan
• Kanoya, Japan
• Kasaoka-shi, Japan
• Kasuga-shi, Japan
• Kobe, Japan
• Kochi, Japan
• Kochi, Japan
• Kyoto, Japan
• Kyoto, Japan
• Minatoku, Japan
• Morioka, Japan
• Morioka, Japan
• Narashino-shi, Japan
• Nishinomiya, Japan
• Nishinomiya, Japan
• Okayama, Japan
• Osaka, Japan
• Ota-shi, Japan
• Ōita, Japan
• Ōsaka, Japan
• Ōta-ku, Japan
• Saijo-shi, Japan
• Saitama, Japan
• Sapporo, Japan
• Sapporo, Japan
• Sendai, Japan
• Shibuya-ku, Japan
• Shinjuku-ku, Japan
• Shizuoka, Japan
• Tachikawa-shi, Japan

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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:

* For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
* Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (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.

Exclusion Criteria:

* For Chronic Migraine participants:

  * 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 of calcitonin gene-related peptide (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.
  * Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).