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A Study of LY2951742 in Participants With Episodic 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. Identifier: NCT02397473
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : July 13, 2018
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Episodic Cluster Headache Drug: LY2951742 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
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
Study Start Date : May 2015
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Proportion of Participants with 50% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline through Week 8 ]
  2. Proportion of Participants with 30% or Greater Reduction from Baseline in Number of Weekly Cluster Headache Attacks [ Time Frame: Baseline through Week 8 ]
  3. 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 ]
  4. Percentage of Participants Developing Anti-Drug Antibodies to LY2951742 [ Time Frame: Baseline through Week 8 ]
  5. Pharmacokinetics (PK): Serum Concentration of LY2951742 [ Time Frame: Week 4, Week 8 ]

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT02397473

  Show 47 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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:
Responsible Party: Eli Lilly and Company 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 Posted: March 25, 2015    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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