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

Status:	Completed
Conditions:	Migraine Headaches
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - 65
Updated:	1/9/2019
Start Date:	November 30, 2015
End Date:	August 14, 2018

A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine

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.

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.

We found this trial at

sites

California Medical Clinic for Headache

Santa Monica, California 90404

Principal Investigator: David Kudrow

Phone: 310-315-1456

from

Santa Monica, CA