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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02797951
Other study ID # 16351
Secondary ID I5Q-MC-CGAR2015-
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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)
See also
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