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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

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.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: LY2951742 Drug: Placebo Phase 2

Detailed Description:

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Migraine
Study Start Date : June 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: LY2951742
LY2951742: 150 milligrams
Drug: LY2951742
Administered subcutaneously once every other week for 12 weeks

Placebo Comparator: Placebo
Placebo: 0.9% Sodium Chloride
Drug: Placebo
Administered subcutaneously once every other week for 12 weeks

Primary Outcome Measures :
  1. Mean change from baseline in the number of migraine headache days in a 28-day period [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline in the number of headache days per 28-day period [ Time Frame: Baseline to 12 weeks ]
  2. Mean change from baseline in the number of migraine attacks per 28-day period [ Time Frame: Baseline to 12 weeks ]
  3. Proportion of responders [ Time Frame: Baseline to 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01625988

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Sponsors and Collaborators
Eli Lilly and Company
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company Identifier: NCT01625988     History of Changes
Other Study ID Numbers: ART-01
ART-01 ( Other Identifier: Eli Lilly and Company )
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms