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

NCT02797951 | Completed Phase 3 Results

• 3 other identifiers: 16351I5Q-MC-CGAR2015-005234-21
• Study Type: interventional
• Target: 165
• Locations: 12 countries
• Sites: 40

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).

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab

  Baseline through End of Study (Up to 4 Years)

Study Arms (1)

Galcanezumab

EXPERIMENTAL

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

Drug: Galcanezumab

Interventions

Galcanezumab DRUG

Administered SC

Also known as: LY2951742

Galcanezumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (40)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Stanford University Hospital

Palo Alto, California, 94304, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Atlanta Center of Medical Research

Atlanta, Georgia, 30331, United States

Location

Michigan Head, Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007-4209, United States

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

Location

Stroyan Research

Toronto, Ontario, M4S 1Y2, Canada

Location

Centre de Traitement Neurologique

Montreal, H2W 1V1, Canada

Location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Suomen Terveystalo

Jyväskylä, 40100, Finland

Location

Terveystalo Pulssi

Turku, 20100, Finland

Location

CHRU de Lille - Hôpital Roger Salengro

Lille, Cedex, 59037, France

Location

APHM Hôpital de la Timone

Marseille, 13385, France

Location

Hôpital de Cimiez

Nice, 06000, France

Location

Hopital Lariboisière

Paris, 75475, France

Location

CHU St Etienne Hopital Nord

Saint-Etienne, 42000, France

Location

Klinikum der Universität München

München, Bavaria, 81377, Germany

Location

Migräne- und Kopfschmerzklinik GmbH & Co. KG

Königstein im Taunus, Hesse, 61462, Germany

Location

Praxis Dr. Philipp Stude

Bochum, North Rhine-Westphalia, 44787, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

401 Army General Hospital of Athens

Athens, Attica, 11525, Greece

Location

Eginition Hospital of Athens

Athens, 11528, Greece

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50139, Italy

Location

Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Fondazione Istituto Neurologico Nationale C. Mondino

Pavia, 27100, Italy

Location

Boerhaave Medisch Centrum

Amsterdam, 1078 VV, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ, Netherlands

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hull Royal Infirmary

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Walton Centre for Neurology and Neurosurgery

Liverpool, Lancashire, L9 7LJ, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35633025 DERIVED

Related Links

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

MeSH Terms

Conditions

Cluster Headache; Headache; Brain Diseases; Central Nervous System Diseases; Headache Disorders; Headache Disorders, Primary; Nervous System Diseases; Neurologic Manifestations; Pain; Trigeminal Autonomic Cephalalgias

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: July 13, 2016
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: February 10, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

NL (2); FI (2); IT (3); DE (5); US (11); GR (2); GB (3); CA (2); ES (2); BE (2); DK (1); FR (5)