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

Lilly

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02614287

15770

I5Q-MC-CGAJ (Other Identifier)

2015-001884-38 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.

Enrollment: 270 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Galcanezumab 120 mg

Experimental group

Description:

Galcanezumab 240mg given as loading dose at first dosing visit followed by 120 mg given by subcutaneous (SC) injection once a month for up to 11 months by auto injector or pre-filled syringe.

Treatment:

Drug: Galcanezumab

Galcanezumab 240 mg

Experimental group

Description:

Galcanezumab 240 mg given by SC injection once a month for up to 12 months by auto injector or pre-filled syringe.

Treatment:

Drug: Galcanezumab