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

Lilly

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02959177

I5Q-JE-CGAN (Other Identifier)

15796

Details and patient eligibility

About

The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.

Enrollment: 459 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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459 participants in 3 patient groups, including a placebo group

120 milligrams (mg) Galcanezumab

Experimental group

Description:

120 mg galcanezumab (LY2951742) administered subcutaneously (SC) once a month for 6 months.

Treatment:

Drug: Galcanezumab

240 mg Galcanezumab

Experimental group

Description:

120 mg galcanezumab (LY2951742) administered SC once a month for 6 months.

Treatment:

Drug: Galcanezumab

Placebo

Placebo Comparator group

Description:

Placebo administered SC once a month for 6 months.

Treatment:

Drug: Placebo