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

Lilly

Status and phase

Completed

Phase 3

Conditions

Episodic Cluster Headache

Chronic Cluster Headache

Treatments

Drug: Galcanezumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02797951

2015-005234-21 (EudraCT Number)

I5Q-MC-CGAR (Other Identifier)

16351

Details and patient eligibility

About

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).

Enrollment

165 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.