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

Phase 3

Completed

Conditions: Episodic Cluster Headache
Chronic Cluster Headache

Interventions: Drug: Galcanezumab

Registration Number: NCT02797951

Lead Sponsor: Eli Lilly and Company

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 165

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Galcanezumab	Galcanezumab	Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)	Baseline through End of Study (Up to 4 Years)	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.
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)	Baseline through End of Study (Up to 4 Years)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab	Baseline through End of Study (Up to 4 Years)	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).

Trial Locations

Locations (40): California Medical Clinic for Headache
🇺🇸
Santa Monica, California, United States
Atlanta Center of Medical Research
🇺🇸
Atlanta, Georgia, United States
Stroyan Research
🇨🇦
Toronto, Ontario, Canada
Walton Centre for Neurology and Neurosurgery
🇬🇧
Liverpool, Lancashire, United Kingdom
Michigan Head, Pain and Neurological Institute
🇺🇸
Ann Arbor, Michigan, United States
Praxis Dr. Philipp Stude
🇩🇪
Bochum, Nordrhein-Westfalen, Germany
Colorado Neurological Institute
🇺🇸
Englewood, Colorado, United States
401 Army General Hospital of Athens
🇬🇷
Athens, Attica, Greece
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States
APHM Hôpital de la Timone
🇫🇷
Marseille Cedex 5, France
New England Institute for Clinical Research
🇺🇸
Stamford, Connecticut, United States
Azienda Ospedaliera Universitaria Careggi
🇮🇹
Firenze, Italy
Centre de Traitement Neurologique
🇨🇦
Montreal, Canada
Hopital Lariboisière
🇫🇷
Paris, France
Universitaetsklinikum Essen
🇩🇪
Essen, Germany
Centre Hospitalier Regional de la Citadelle
🇧🇪
Liege, Belgium
Istituto Neurologico Carlo Besta
🇮🇹
Milano, Italy
CHRU de Lille - Hôpital Roger Salengro
🇫🇷
Lille, Cedex, France
Universitätsklinikum Jena
🇩🇪
Jena, Thüringen, Germany
Eginition Hospital of Athens
🇬🇷
Athens, Greece
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
Suomen Terveystalo
🇫🇮
Jyväskylä, Finland
Fondazione Istituto Neurologico Nationale C. Mondino
🇮🇹
Pavia, Italy
CHU St Etienne Hopital Nord
🇫🇷
Saint Etienne Cedex 2, France
Migräne- und Kopfschmerzklinik GmbH & Co. KG
🇩🇪
Königstein, Hessen, Germany
Mayo Clinic Hospital
🇺🇸
Phoenix, Arizona, United States
Stanford University Hospital
🇺🇸
Palo Alto, California, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Glostrup Hospital
🇩🇰
Glostrup, Denmark
Clinical Trials of South Carolina
🇺🇸
Charleston, South Carolina, United States
Terveystalo Pulssi
🇫🇮
Turku, Finland
Klinikum der Universität München
🇩🇪
München, Bayern, Germany
Hôpital de Cimiez
🇫🇷
Nice, France
Canisius-Wilhelmina Ziekenhuis
🇳🇱
Nijmegen, Netherlands
Hospital Universitari Vall d'Hebron
🇪🇸
Barcelona, Spain
Boerhaave Medisch Centrum
🇳🇱
Amsterdam, Netherlands
Hospital Clínico Universitario de Valencia
🇪🇸
Valencia, Spain
Hull Royal Infirmary
🇬🇧
Hull, East Yorkshire, United Kingdom
Royal Stoke University Hospital
🇬🇧
Stoke-on-Trent, Staffordshire, United Kingdom
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States