Trial record 1 of 5 for:    LY2951742
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A Study of LY2951742 in Participants With Migraine Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02163993
First received: June 12, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

The main purpose of this study is to evaluate whether the study drug known as LY2951742 is safe and effective in the prevention of migraine headaches. The study will last between 28 and 36 weeks.


Condition Intervention Phase
Migraine Headache
Drug: LY2951742
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean Change from Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change from Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Proportion of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [ Time Frame: Baseline up to 12 Weeks ] [ Designated as safety issue: No ]
  • Mean Change from Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Mean Change from Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Scores [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Serum Concentration of LY2951742 [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: No ]
  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Developing Anti-drug Antibodies to LY2951742 [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores [ Time Frame: Baseline through 12 Weeks ] [ Designated as safety issue: Yes ]
  • Mean Change from Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Mean Change from Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 402
Study Start Date: July 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 LY2951742
Dose 1 of LY2951742 given as subcutaneous (SQ) injections once every 28 days during a 12 week treatment period.
Drug: LY2951742
Administered SQ
Experimental: Dose 2 LY2951742
Dose 2 of LY2951742 given as SQ injections once every 28 days during a 12 week treatment period.
Drug: LY2951742
Administered SQ
Experimental: Dose 3 LY2951742
Dose 3 of LY2951742 given as SQ injections once every 28 days during a 12 week treatment period.
Drug: LY2951742
Administered SQ
Experimental: Dose 4 LY2951742
Dose 4 of LY2951742 given as SQ injections once every 28 days during a 12 week treatment period.
Drug: LY2951742
Administered SQ
Placebo Comparator: Placebo
Placebo given as SQ injections once every 28 days during a 12 week treatment period.
Drug: Placebo
Administered SQ

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with a history of migraine of at least 1 year prior to enrollment.
  • Migraine onset prior to age 50.

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 CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
  • History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.
  • Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.
  • Failure to respond to more than two adequately dosed effective migraine prevention treatments.
  • Evidence of significant active 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: NCT02163993

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

  Show 37 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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02163993     History of Changes
Other Study ID Numbers: 15414, I5Q-MC-CGAB
Study First Received: June 12, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014