A Study in Patients With Cluster Headache

Phase 1

• Conditions: Episodic Cluster Headache, Chronic Cluster Headache; MedDRA version: 20.0Level: PTClassification code 10059133Term: Cluster headacheSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005234-21-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-10
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 324

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 304
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of open-label galcanezumab within the context of dosing during expected medical practice in eligible patients with episodic or chronic cluster headache.;Secondary Objective: 1. To characterize the reasons for discontinuation and AEs of interest for galcanezumab. <br>2. To characterize the immunogenicity of galcanezumab.;Primary end point(s): 1.Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious AEs (SAEs) <br>[Time Frame: Baseline through End of Study <br>2.Number of Participants With Suicidal Ideation and Behaviors Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) <br>[Time Frame: Baseline through End of Study <br>;Timepoint(s) of evaluation of this end point: Baseline through End of Study (Approximately 5 Years)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of Participants with Treatment Emergent Anti-Galcanezumab Antibodies ;Timepoint(s) of evaluation of this end point: Baseline through End of Study (Approximately 5 Years)