A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache

Chronic Cluster Headache Clinical Trial

Official title:

A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797951
• Other study ID #: 16351
• Secondary ID: I5Q-MC-CGAR2015-
• Status: Completed
• Phase: Phase 3
• Start date: July 13, 2016
• Est. completion date: January 21, 2021

Study information

• Verified date: January 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Chronic Cluster Headache
• Cluster Headache
• Episodic Cluster Headache
• Headache

Intervention

Drug:
• Galcanezumab
Administered SC

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Centre Hospitalier Regional de la Citadelle	Liege
Canada	Centre de Traitement Neurologique	Montreal
Canada	Stroyan Research	Toronto	Ontario
Denmark	Glostrup Hospital	Glostrup
Finland	Suomen Terveystalo	Jyväskylä
Finland	Terveystalo Pulssi	Turku
France	CHRU de Lille - Hôpital Roger Salengro	Lille	Cedex
France	APHM Hôpital de la Timone	Marseille Cedex 5
France	Hôpital de Cimiez	Nice
France	Hopital Lariboisière	Paris
France	CHU St Etienne Hopital Nord	Saint Etienne Cedex 2
Germany	Praxis Dr. Philipp Stude	Bochum	Nordrhein-Westfalen
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitätsklinikum Jena	Jena	Thüringen
Germany	Migräne- und Kopfschmerzklinik GmbH & Co. KG	Königstein	Hessen
Germany	Klinikum der Universität München	München	Bayern
Greece	401 Army General Hospital of Athens	Athens	Attica
Greece	Eginition Hospital of Athens	Athens
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Istituto Neurologico Carlo Besta	Milano
Italy	Fondazione Istituto Neurologico Nationale C. Mondino	Pavia
Netherlands	Boerhaave Medisch Centrum	Amsterdam
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Clínico Universitario de Valencia	Valencia
United Kingdom	Hull Royal Infirmary	Hull	East Yorkshire
United Kingdom	Walton Centre for Neurology and Neurosurgery	Liverpool	Lancashire
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent	Staffordshire
United States	Michigan Head, Pain and Neurological Institute	Ann Arbor	Michigan
United States	Atlanta Center of Medical Research	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Stanford University Hospital	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	California Medical Clinic for Headache	Santa Monica	California
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)	A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase.; An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.	Baseline through End of Study (Up to 4 Years)
Primary	Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).; Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.; Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.	Baseline through End of Study (Up to 4 Years)
Secondary	Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab	A participant is considered TE-ADA positive if: ADA "not present" baseline result and any subsequent "present" postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or; ADA "present" baseline result and any subsequent "present" postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted).	Baseline through End of Study (Up to 4 Years)

External Links

•   A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache