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Trial record 2 of 17 for:    LY2951742

A Study of LY2951742 in Participants With Chronic Cluster Headache

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02438826
First received: May 6, 2015
Last updated: September 2, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Chronic 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 With a Long-Term Open-Label Extension in Patients With Chronic 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 Weekly Cluster Headache Attack Frequency [ Time Frame: Baseline, Week 4 ]

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

Estimated Enrollment: 162
Study Start Date: June 2015
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02438826

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

  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
  More Information

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 )
Study First Received: May 6, 2015
Last Updated: September 2, 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

ClinicalTrials.gov processed this record on September 21, 2017