A Study Of Galcanezumab In Participants With Episodic Cluster Headache

• Status: Completed
• Trial end date: 2018-06-04
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Have a diagnosis of cluster headache as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1 month.

• Participants are able to distinguish cluster headache attacks from other headaches.

Exclusion Criteria:

• Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.

• 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).

• Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.

• 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.