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A Study of LY2951742 in Participants With Episodic Cluster Headache

This study is currently recruiting participants.
Verified October 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02397473
First Posted: March 25, 2015
Last Update Posted: October 19, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as LY2951742 in participants with episodic cluster headaches.

Condition Intervention Phase
Episodic Cluster Headache Drug: LY2951742 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean Change from Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline and at One Time Point on or Before Study Completion (Week 8) ]

Secondary Outcome Measures:
  • Proportion of Participants with 50% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline through Week 8 ]
  • Proportion of Participants with 30% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline through Week 8 ]
  • Proportion of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) [ Time Frame: Week 4, Week 8 ]
  • Percentage of Participants Developing Anti-Drug Antibodies to LY2951742 [ Time Frame: Baseline through Week 8 ]
  • Pharmacokinetics (PK): Serum Concentration of LY2951742 [ Time Frame: Week 4, Week 8 ]

Estimated Enrollment: 162
Study Start Date: May 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2951742
LY2951742 administered subcutaneously (SC) every 30 days during an 8 week treatment period.
Drug: LY2951742
Administered SC
Placebo Comparator: Placebo
Placebo administered SC every 30 days during an 8 week treatment period.
Drug: Placebo
Administered SC

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of ≥1 month.
  • Participants are able to distinguish cluster headache attacks from other headaches.

Exclusion Criteria:

  • Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
  • 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).
  • Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
  • 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.
  Contacts and Locations
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): NCT02397473


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 49 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02397473     History of Changes
Other Study ID Numbers: 15780
I5Q-MC-CGAL ( Other Identifier: Eli Lilly and Company )
2015-000149-22 ( EudraCT Number )
First Submitted: March 19, 2015
First Posted: March 25, 2015
Last Update Posted: October 19, 2017
Last Verified: October 2017

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