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

Lilly

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02959190

16108

I5Q-JE-CGAP (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.

Enrollment: 311 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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311 participants in 6 patient groups

120mg/120mg Galcanezumab - Episodic Migraine (EM)

Experimental group

Description:

240 milligram (loading dose) of Galcanezumab at first dosing visit followed by 120 milligram (mg) once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.

Treatment:

Drug: Galcanezumab

240mg/240mg Galcanezumab - EM

Experimental group

Description:

240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.

Treatment:

Drug: Galcanezumab

Placebo/ 120mg Galcanezumab - EM

Experimental group

Description:

240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.

Treatment:

Drug: Galcanezumab

Placebo/ 240mg Galcanezumab - EM

Experimental group

Description:

240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.

Treatment:

Drug: Galcanezumab

120mg Galcanezumab - CM

Experimental group

Description:

240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.

Treatment:

Drug: Galcanezumab

240mg Galcanezumab - CM

Experimental group

Description:

240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.

Treatment:

Drug: Galcanezumab