Clinical trial NCT02797951: A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Official title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Cluster Headache
Chronic Cluster Headache
Keywords: cluster headache
headache
brain diseases
central nervous system diseases
headache disorders
headache disorders, primary
nervous system diseases
neurologic manifestations
pain
trigeminal autonomic cephalalgias
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
timeFrame: Baseline through End of Study (Up to 4 Years)
measure: Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline through End of Study (Up to 4 Years)
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab
timeFrame: Baseline through End of Study (Up to 4 Years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Palo Alto
country: United States
facility: Stanford University Hospital
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic for Headache
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center of Medical Research
state: Georgia
city: Ann Arbor
country: United States
facility: Michigan Head, Pain and Neurological Institute
state: Michigan
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: Centre Hospitalier Regional de la Citadelle
city: Toronto
country: Canada
facility: Stroyan Research
state: Ontario
city: Montreal
country: Canada
facility: Centre de Traitement Neurologique
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Jyväskylä
country: Finland
facility: Suomen Terveystalo
city: Turku
country: Finland
facility: Terveystalo Pulssi
city: Lille
country: France
facility: CHRU de Lille - Hôpital Roger Salengro
state: Cedex
city: Marseille Cedex 5
country: France
facility: APHM Hôpital de la Timone
city: Nice
country: France
facility: Hôpital de Cimiez
city: Paris
country: France
facility: Hopital Lariboisière
city: Saint Etienne Cedex 2
country: France
facility: CHU St Etienne Hopital Nord
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: Königstein
country: Germany
facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG
state: Hessen
city: Bochum
country: Germany
facility: Praxis Dr. Philipp Stude
state: Nordrhein-Westfalen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Athens
country: Greece
facility: 401 Army General Hospital of Athens
state: Attica
city: Athens
country: Greece
facility: Eginition Hospital of Athens
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: Istituto Neurologico Carlo Besta
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nationale C. Mondino
city: Amsterdam
country: Netherlands
facility: Boerhaave Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: East Yorkshire
city: Liverpool
country: United Kingdom
facility: Walton Centre for Neurology and Neurosurgery
state: Lancashire
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Riesenberg R, Gaul C, Stroud CE, Dong Y, Bangs ME, Wenzel R, Martinez JM, Oakes TM. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. 2022 Oct;42(11-12):1225-1235. doi: 10.1177/03331024221103509. Epub 2022 May 27.