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

Primary Purpose

Episodic Cluster Headache, Chronic Cluster Headache

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Galcanezumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Cluster Headache focused on measuring cluster headache, headache, brain diseases, central nervous system diseases, headache disorders, headache disorders, primary, nervous system diseases, neurologic manifestations, pain, trigeminal autonomic cephalalgias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Hospital
  • Stanford University Hospital
  • California Medical Clinic for Headache
  • Colorado Neurological Institute
  • New England Institute for Clinical Research
  • University of South Florida
  • Atlanta Center of Medical Research
  • Michigan Head, Pain and Neurological Institute
  • Thomas Jefferson University
  • Clinical Trials of South Carolina
  • Northwest Clinical Research Center
  • Universitair Ziekenhuis Gent
  • Centre Hospitalier Regional de la Citadelle
  • Stroyan Research
  • Centre de Traitement Neurologique
  • Glostrup Hospital
  • Suomen Terveystalo
  • Terveystalo Pulssi
  • CHRU de Lille - Hôpital Roger Salengro
  • APHM Hôpital de la Timone
  • Hôpital de Cimiez
  • Hopital Lariboisière
  • CHU St Etienne Hopital Nord
  • Klinikum der Universität München
  • Migräne- und Kopfschmerzklinik GmbH & Co. KG
  • Praxis Dr. Philipp Stude
  • Universitätsklinikum Jena
  • Universitaetsklinikum Essen
  • 401 Army General Hospital of Athens
  • Eginition Hospital of Athens
  • Azienda Ospedaliera Universitaria Careggi
  • Istituto Neurologico Carlo Besta
  • Fondazione Istituto Neurologico Nationale C. Mondino
  • Boerhaave Medisch Centrum
  • Canisius-Wilhelmina Ziekenhuis
  • Hospital Universitari Vall d'Hebron
  • Hospital Clínico Universitario de Valencia
  • Hull Royal Infirmary
  • Walton Centre for Neurology and Neurosurgery
  • Royal Stoke University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Galcanezumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 9, 2016
Last Updated
January 20, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02797951
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2016 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Galcanezumab
Arm Type
Experimental
Arm Description
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
Intervention Type
Drug
Intervention Name(s)
Galcanezumab
Other Intervention Name(s)
LY2951742
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Description
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.
Time Frame
Baseline through End of Study (Up to 4 Years)
Title
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
Baseline through End of Study (Up to 4 Years)
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab
Description
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).
Time Frame
Baseline through End of Study (Up to 4 Years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Stanford University Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta Center of Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Michigan Head, Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007-4209
Country
United States
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Stroyan Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
Centre de Traitement Neurologique
City
Montreal
ZIP/Postal Code
H2W 1V1
Country
Canada
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Suomen Terveystalo
City
Jyväskylä
ZIP/Postal Code
40100
Country
Finland
Facility Name
Terveystalo Pulssi
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
CHRU de Lille - Hôpital Roger Salengro
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
APHM Hôpital de la Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Hôpital de Cimiez
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hopital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU St Etienne Hopital Nord
City
Saint Etienne Cedex 2
ZIP/Postal Code
42000
Country
France
Facility Name
Klinikum der Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Migräne- und Kopfschmerzklinik GmbH & Co. KG
City
Königstein
State/Province
Hessen
ZIP/Postal Code
61462
Country
Germany
Facility Name
Praxis Dr. Philipp Stude
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
401 Army General Hospital of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11525
Country
Greece
Facility Name
Eginition Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nationale C. Mondino
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Boerhaave Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1078 VV
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Walton Centre for Neurology and Neurosurgery
City
Liverpool
State/Province
Lancashire
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
35633025
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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/WEzAu0Rzqgg2YY8AKeKSC
Description
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache

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

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