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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02797951
Recruitment Status : Enrolling by invitation
First Posted : June 14, 2016
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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).

Condition or disease Intervention/treatment Phase
Episodic Cluster Headache Chronic Cluster Headache Drug: Galcanezumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache
Actual Study Start Date : July 13, 2016
Estimated Primary Completion Date : July 29, 2020
Estimated Study Completion Date : August 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Galcanezumab
Galcanezumab given subcutaneously (SQ) up to once a month.
Drug: Galcanezumab
Administered SQ
Other Name: LY2951742




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious AEs (SAEs) [ Time Frame: Baseline through End of Study (Approximately 4 Years) ]
  2. Number of Participants With Suicidal Ideation and Behaviors Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through End of Study (Approximately 4 Years) ]

Secondary Outcome Measures :
  1. Number of Participants with Treatment Emergent Anti-Galcanezumab Antibodies [ Time Frame: Baseline through End of Study (Approximately 4 Years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797951


  Show 42 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02797951     History of Changes
Other Study ID Numbers: 16351
I5Q-MC-CGAR ( Other Identifier: Eli Lilly and Company )
2015-005234-21 ( EudraCT Number )
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
cluster headache
headache
brain diseases
central nervous system diseases
headache disorders
headache disorders, primary
nervous system diseases
neurologic manifestations
pain
trigeminal autonomic cephalalgias

Additional relevant MeSH terms:
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Headache
Cluster Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases