A Study Of Galcanezumab In Participants With Episodic Cluster Headache

Lilly

Status and phase: Completed; Phase 3

Conditions: Episodic Cluster Headache

Treatments: Drug: Placebo; Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02397473

15780

I5Q-MC-CGAL (Other Identifier)

2015-000149-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 2 patient groups, including a placebo group

Galcanezumab 300mg

Experimental group

Description:

Galcanezumab 300mg administered subcutaneously (SC) every 30 days during an 8 week treatment period.

Treatment:

Drug: Galcanezumab

Placebo

Placebo Comparator group

Description:

Placebo administered SC every 30 days during an 8 week treatment period.

Treatment:

Drug: Placebo