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

January 20, 2022 updated by: Eli Lilly and Company

A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Liege, Belgium, 4000
        • Centre Hospitalier Regional De La Citadelle
  • Canada
      • Montreal, Canada, H2W 1V1
        • Centre de traitement neurologique
    • Ontario
      • Toronto, Ontario, Canada, M4S 1Y2
        • Stroyan Research
  • Denmark
      • Glostrup, Denmark, 2600
        • Glostrup Hospital
  • Finland
      • Jyväskylä, Finland, 40100
        • Suomen Terveystalo
      • Turku, Finland, 20100
        • Terveystalo Pulssi
  • France
      • Marseille Cedex 5, France, 13385
        • APHM Hopital de la Timone
      • Nice, France, 06000
        • Hôpital de Cimiez
      • Paris, France, 75475
        • Hôpital Lariboisière
      • Saint Etienne Cedex 2, France, 42000
        • CHU St Etienne Hopital Nord
    • Cedex
      • Lille, Cedex, France, 59037
        • CHRU de Lille - Hôpital Roger Salengro
  • Germany
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
    • Bayern
      • München, Bayern, Germany, 81377
        • Klinikum der Universität München
    • Hessen
      • Königstein, Hessen, Germany, 61462
        • Migräne- und Kopfschmerzklinik GmbH & Co. KG
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44787
        • Praxis Dr. Philipp Stude
    • Thüringen
      • Jena, Thüringen, Germany, 07747
        • Universitatsklinikum Jena
  • Greece
      • Athens, Greece, 11528
        • Eginition Hospital of Athens
    • Attica
      • Athens, Attica, Greece, 11525
        • 401 Army General Hospital of Athens
  • Italy
      • Firenze, Italy, 50139
        • Azienda Ospedaliera Universitaria Careggi
      • Milano, Italy, 20133
        • Istituto Neurologico Carlo Besta
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico Nationale C. Mondino
  • Netherlands
      • Amsterdam, Netherlands, 1078 VV
        • Boerhaave Medisch Centrum
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
  • United Kingdom
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
    • Lancashire
      • Liverpool, Lancashire, United Kingdom, L9 7LJ
        • Walton Centre For Neurology And Neurosurgery
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Hospital
      • Santa Monica, California, United States, 90404
        • California Medical Clinic for Headache
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Colorado Neurological Institute
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Clinical Research
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center of Medical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head, Pain and Neurological Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
    • Washington
      • Bellevue, Washington, United States, 98007-4209
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Galcanezumab
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
Drug: Galcanezumab
Administered SC
Other Names:
  • LY2951742

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Time Frame: 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.
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)
Time Frame: 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.
Baseline through End of Study (Up to 4 Years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab
Time Frame: 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).
Baseline through End of Study (Up to 4 Years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2016

Primary Completion (ACTUAL)

January 21, 2021

Study Completion (ACTUAL)

January 21, 2021

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (ESTIMATE)

June 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16351
  • I5Q-MC-CGAR (OTHER: Eli Lilly and Company)
  • 2015-005234-21 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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