A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine



Status:Completed
Conditions:Migraine Headaches, Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:4/17/2018
Start Date:January 2014
End Date:March 2015

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study Comparing the Efficacy and Safety of Two Doses of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of High Frequency Episodic Migraine

The purpose of this study is to determine whether monthly subcutaneous administration of
LBR-101 is safe and provides migraine prevention in subjects with high frequency episodic
migraine.


Inclusion Criteria:

- Males or females aged 18 to 65 years of age.

- A signed and dated informed consent document indicating that the subject has been
informed of all pertinent aspects of the study including any known and potential risks
and available alternative treatments.

- Subjects fulfilling criteria for episodic migraine as per the Second Edition of The
International Headache Society (Olesen and Steiner 2004), who experience migraine at
high frequency as follows:

i. History of headaches on more than 8 days per month for at least 3 months prior to
screening

ii. Verification of headache frequency through prospectively collected baseline information
during the 28-day run-in phase demonstrating headaches (of any type) on at least 8 days
with at total of 8 to 14 days* fulfilling criteria for migraine.

*Operational definition for migraine and probable migraine days are presented in the
statistical section of this protocol.

- Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and
120 kg, inclusive.

- Demonstrated compliance with the electronic headache diary during the run-in period by
entry of headache data on a minimum of 22/28 days (80% compliance).

Exclusion Criteria:

- Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic
reasons requiring injections in the head, face, or neck during the six months prior to
screening.

- Subject uses medications containing opioids (including codeine) or barbiturates
(including Fiorinal®, Fioricet®, or any other combination containing butalbital) on
more than 4 days per month for the treatment of migraine or for any other reason.

- Failed > 2 medication categories or > 3 preventive medications (within two medication
categories) due to lack of efficacy for prophylactic treatment of episodic or chronic
migraine after an adequate therapeutic trial

- Treatment with an investigational drug or device within 30 days of study entry or any
prior exposure to a monoclonal antibody targeting the CGRP pathway.
We found this trial at
59
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Kalamazoo, Michigan
208
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Kalamazoo, MI
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Anaheim, California
1960
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Anaheim, CA
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Ann Arbor, Michigan
164
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Ann Arbor, MI
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Arlington, TX
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436
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Atlanta, GA
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Austin, TX
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Boulder, Colorado
1174
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Boulder, CO
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Bristol, Tennessee
237
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Bristol, TN
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Brockton, Massachusetts
642
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Brockton, MA
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482
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Bronx, NY
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104
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Canton, OH
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Charlottesville, Virginia
278
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Charlottesville, VA
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Cincinnati, Ohio
98
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Cincinnati, OH
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127
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Cleveland, OH
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Columbus, Ohio
1
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Columbus, OH
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Decatur, Georgia
433
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Decatur, GA
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DeLand, FL
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Douglasville, Georgia
439
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Douglasville, GA
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Evansville, Indiana
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Evansville, IN
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Fullerton, California
1960
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Fullerton, CA
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1651
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Gilbert, AZ
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Golden Valley, Minnesota
630
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Golden Valley, MN
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Greensboro, North Carolina
321
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Greensboro, NC
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989
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Hialeah, FL
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Hollywood, Florida
978
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Hollywood, FL
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Jacksonville, Florida
670
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Jacksonville, FL
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Kansas City, Missouri
618
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Kansas City, MO
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628
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Lenexa, KS
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Little Rock, Arkansas 72205
624
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Little Rock, AR
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Long Beach, California
1977
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Long Beach, CA
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788
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Maitland, FL
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936
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Mansfield, TX
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Memphis, Tennessee
508
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Memphis, TN
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Mount Pleasant, South Carolina
525
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Mount Pleasant, SC
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Nashville, Tennessee
332
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New Bedford, Massachusetts
642
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New Bedford, MA
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Oceanside, California
1949
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Oklahoma City, Oklahoma
849
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Oklahoma City, OK
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795
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Orlando, FL
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Ormond Beach, Florida
746
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Philadelphia, Pennsylvania
416
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Philadelphia, PA
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Phoenix, AR
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Port Orange, Florida
756
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Raleigh, North Carolina
374
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Raleigh, NC
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1940
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Reno, NV
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Roanoke, Virginia
249
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Roanoke, VA
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Saint Louis, Missouri
394
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Salt Lake City, Utah
1513
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San Francisco, California
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Scottsdale, Arizona
1653
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South Miami, Florida
997
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South Miami, FL
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Springfield, Massachusetts
563
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Springfield, Missouri
585
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Stamford, Connecticut
503
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Stanford, California
2101
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Walnut Creek, California
2086
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Watertown, Massachusetts
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Winston-Salem, North Carolina 27103
307
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Worcester, Massachusetts
604
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Worcester, MA
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