A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache

Status:	Enrolling by invitation
Conditions:	Migraine Headaches
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - Any
Updated:	4/5/2019
Start Date:	July 13, 2016
End Date:	August 24, 2021

A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

The main purpose of this study is to assess the long-term safety and tolerability of
galcanezumab administered up to once monthly in participants with episodic or chronic cluster
headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM
(NCT02438826).

Inclusion Criteria:

- Participants who participated in and completed either study CGAL or study CGAM.

- Investigator judges the participant as reliable to follow all study procedures, keep
all study visits, and be compliant with study requirements.

Exclusion Criteria:

- Current enrollment in or discontinuation within the last 30 days from, a clinical
trial involving any investigational drug or device (with the exception of Study CGAL
or Study CGAM).

- Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF)
(with the exception of Study CGAL or Study CGAM).

- A history of migraine variants that could implicate or could be confused with
ischemia.

- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
proteins.

- A history or presence of other medical illness that indicates a medical problem that
would preclude study participation.

- Evidence of significant active or unstable psychiatric disease, in the opinion of the
investigator.

- Women who are pregnant or nursing.

We found this trial at

sites

Michigan Head Pain & Neurological Institute

Ann Arbor, Michigan 48104

Principal Investigator: Joel Saper

Phone: 734-677-6000

from

Ann Arbor, MI