A Study of LY2951742 in Participants With Migraine

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: NCT01625988
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):
Eli Lilly and Company

June 20, 2012
June 22, 2012
May 7, 2014
June 2012
September 2013   (Final data collection date for primary outcome measure)
Mean change from baseline in the number of migraine headache days in a 28-day period [ Time Frame: Baseline to 12 weeks ]
Same as current
Complete list of historical versions of study NCT01625988 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
A Study of LY2951742 in Participants With Migraine
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine
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.

The study is comprised of 4 trial periods:

  1. Screening and washout
  2. Baseline for assessment of the type, frequency and severity of headaches (4 weeks)
  3. Treatment (12 weeks)
  4. Follow-up (12 weeks)
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Migraine Headache
  • Drug: LY2951742
    Administered subcutaneously once every other week for 12 weeks
  • Drug: Placebo
    Administered subcutaneously once every other week for 12 weeks
  • Experimental: LY2951742
    LY2951742: 150 milligrams
    Intervention: Drug: LY2951742
  • Placebo Comparator: Placebo
    Placebo: 0.9% Sodium Chloride
    Intervention: Drug: Placebo
Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014 Sep;13(9):885-92. doi: 10.1016/S1474-4422(14)70128-0. Epub 2014 Aug 10.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2013
September 2013   (Final data collection date for primary outcome measure)

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 greater than (>) 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
ART-01 ( Other Identifier: Eli Lilly and Company )
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
April 2014

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