A Study of LY2951742 in Patients With Migraine



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:June 2012
End Date:October 2013
Contact:Arteaus Therapeutics
Email:Arteaus@Choruspharma.com

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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)

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
We found this trial at
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Melbourne, Florida 32935
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12015 E. 46th Avenue
Denver, Colorado 80239
303-477-1880
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Austin, TX
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Bristol, Tennessee 37620
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Chattanooga, Tennessee 37421
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Dallas, Texas 75231
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Encino, California 91316
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Fremont, NE
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Greensboro, North Carolina 27408
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Henderson, Nevada 89052
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Houston, Texas 77074
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Huntington Beach, California 92647
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Kalamazoo, Michigan 49009
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Los Alamitos, California 90720
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Maclean, Virginia 22102
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Maitland, Florida 32751
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Newport Beach, California 92660
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Oklahoma City, Oklahoma 73103
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Pembroke Pines, Florida
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Phoenix, Arizona 85023
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San Diego, California 92108
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San Diego, California 92123
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San Francisco, California
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Santa Monica, California 90404
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Springfield, Missouri 65807
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Sunrise, Florida 33351
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Torrance, California 90502
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Watertown, Massachusetts 02472
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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