A Study of Galcanezumab in Participants With Chronic Cluster Headache

Lilly

Status and phase: Completed; Phase 3

Conditions: Chronic Cluster Headache

Treatments: Drug: Galcanezumab 300 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02438826

15781

I5Q-MC-CGAM (Other Identifier)

2014-005429-11 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
• 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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240 participants in 2 patient groups, including a placebo group

Galcanezumab 300 mg

Experimental group

Description:

Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.

Treatment:

Drug: Galcanezumab 300 mg

Placebo

Placebo Comparator group

Description:

Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.

Treatment:

Drug: Placebo

Drug: Galcanezumab 300 mg