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A Study of LY2951742 in Participants With Migraine

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ClinicalTrials.gov Identifier: NCT01625988
Recruitment Status : Completed
First Posted : June 22, 2012
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 20, 2012
First Posted Date  ICMJE June 22, 2012
Results First Submitted Date  ICMJE November 18, 2019
Results First Posted Date  ICMJE January 9, 2020
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE June 28, 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
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 ]
The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2012)
Mean change from baseline in the number of migraine headache days in a 28-day period [ Time Frame: Baseline to 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2019)
  • 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 ]
    Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
  • Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase [ Time Frame: Baseline, 12 weeks ]
    A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
  • Percentage of Responders [ Time Frame: Baseline, 4, 8, and 12 weeks ]
    Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2012)
  • Mean change from baseline in the number of headache days per 28-day period [ Time Frame: Baseline to 12 weeks ]
  • Mean change from baseline in the number of migraine attacks per 28-day period [ Time Frame: Baseline to 12 weeks ]
  • Proportion of responders [ Time Frame: Baseline to 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY2951742 in Participants With Migraine
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine
Brief Summary To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in migraineurs with or without aura during 3 months of treatment.
Detailed Description

The study is comprised of 4 trial periods:

  1. Screening and washout (5-45 days)
  2. Baseline for assessment of the type, frequency, and severity of headaches (28-38 days)
  3. Treatment (12 weeks)
  4. Follow-up (12 weeks)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine Headache
Intervention  ICMJE
  • Drug: LY2951742
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: LY2951742
    LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
    Intervention: Drug: LY2951742
  • Placebo Comparator: Placebo
    Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2019)
218
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2012)
190
Actual Study Completion Date  ICMJE September 18, 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches
  • Women of child-bearing potential (not surgically sterile or at least 1 year post-menopause) must test negative for pregnancy at the time of screening based on a serum pregnancy test and must agree to use a reliable method of birth control during the study and for 3 months following completion of participation in the study
  • Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator
  • Must not be on any migraine prevention therapy, including botulinum toxin (Botox)
  • Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed

Exclusion Criteria:

  • Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Previous completion or withdrawal from this study or any other study investigating LY2951742 or other therapeutic antibodies that target calcitonin gene-related peptide (CGRP)
  • History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
  • History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization
  • Evidence of significant active psychiatric disease including, but not limited to, manic depressive illness, schizophrenia, generalized anxiety disorder, obsessive compulsive disorder, personality disorders, or other serious mood, anxiety, depression, or substance use disorders
  • Have a history or presence of any other medical illness that in the judgment of the Investigator, indicates a medical problem that would preclude study participation
  • Women who are pregnant or nursing
  • Confirmed corrected QT (QTc) interval >470 milliseconds (msec) for women and >450 for men
  • Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence
  • In the opinion of the Investigator, have no other issues that would interfere with compliance with the study requirements and completion of evaluations required for this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01625988
Other Study ID Numbers  ICMJE ART-01
ART-01 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP