A Study in Patients With Cluster Headache

• Register: EUCTR
• Last refreshed on: 19 April 2022
• Main ID: EUCTR2015-005234-21-ES
• Date of registration: 15/07/2016
• Prospective Registration: Yes
• Primary sponsor: Lilly S.A.
• Public title: A Study in Patients With Cluster Headache
• Scientific title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (galcanezumab) in Patients with Episodic or Chronic Cluster Headache
• Date of first enrolment: 09/08/2016
• Target sample size: 324
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005234-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom

Contacts

• Name: Maria Jose Hernandez
• Affiliation: Lilly S.A.

• Name: Maria Jose Hernandez
• Affiliation: Lilly S.A.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Episodic Cluster Headache, Chronic Cluster Headache
MedDRA version: 19.0 Level: PT Classification code 10059133 Term: Cluster headache System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: Galcanezumab
Product Code: LY2951742
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: galcanezumab
Other descriptive name: LY2951742
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): 1.Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious AEs (SAEs)
[Time Frame: Baseline through End of Study
2.Number of Participants With Suicidal Ideation and Behaviors Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
[Time Frame: Baseline through End of Study

Secondary Objective: 1. To characterize the reasons for discontinuation and AEs of interest for galcanezumab.
2. To characterize the immunogenicity of galcanezumab.

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.

Timepoint(s) of evaluation of this end point: Baseline through End of Study (Approximately 5 Years)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Baseline through End of Study (Approximately 5 Years)

Secondary end point(s): Number of Participants with Treatment Emergent Anti-Galcanezumab Antibodies

Secondary ID(s)

2015-005234-21-DE

I5Q-MC-CGAR

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 05/08/2016
Contact:

Results

• Results available: Yes
• Date Posted: 05/02/2022
• Date Completed: 21/01/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-005234-21/results