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A Study of LY2951742 in Participants With Chronic Cluster Headache

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ClinicalTrials.gov Identifier: NCT02438826
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the efficacy of the study drug known as LY2951742 in participants with chronic cluster headache.

Condition or disease Intervention/treatment Phase
Chronic Cluster Headache Drug: LY2951742 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 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 With a Long-Term Open-Label Extension in Patients With Chronic Cluster Headache
Study Start Date : June 2015
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arm Intervention/treatment
Experimental: LY2951742
LY2951742 administered by subcutaneous (SQ) injection every 30 days for 12 weeks. Open label extension with LY2951742 administered by SQ injection every 30 days for 12 months.
Drug: LY2951742
Administered SQ
Placebo Comparator: Placebo
Placebo administered by SQ injection every 30 Days for 12 weeks. Open label extension with LY2951742 administered by SQ injection every 30 days for 12 months.
Drug: LY2951742
Administered SQ
Drug: Placebo
Administered SQ



Primary Outcome Measures :
  1. Mean Change from Baseline in Weekly Cluster Headache Attack Frequency [ Time Frame: Baseline, Week 4 ]

Secondary Outcome Measures :
  1. Proportion of Participants with a ≥50% Reduction in the Weekly Number of Cluster Headache Attacks [ Time Frame: Baseline through Week 12 ]
  2. Proportion of Participants with a ≥30% Reduction in the Weekly Number of Cluster Headache Attacks [ Time Frame: Baseline through Week 12 ]
  3. Mean Change from Baseline in Weekly Cluster Headache Attack Frequency [ Time Frame: Baseline, Week 2, Week 6, Week 8, Week 10, and Week 12 ]
  4. Percentage of Participants Developing Anti-Drug Antibodies to LY2951742 [ Time Frame: Baseline through Week 12 ]
  5. Pharmacokinetics (PK): Serum Concentration of LY2951742 [ Time Frame: Week 2, Week 4, Week 8, Week 12 ]
  6. 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, Week 12 ]


Information from the National Library of Medicine

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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 chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02438826


  Show 48 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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02438826     History of Changes
Other Study ID Numbers: 15781
I5Q-MC-CGAM ( Other Identifier: Eli Lilly and Company )
2014-005429-11 ( EudraCT Number )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

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