Assessment of LBR-101 In Chronic Migraine



Status:Completed
Conditions: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, Double-Dummy, Placebo-Controlled, Parallel Group, Multi-Dose Study Comparing the Efficacy and Safety of Subcutaneous LBR-101 With Placebo for the Preventive Treatment of Chronic Migraine

The purpose of the study is to determine whether monthly subcutaneous administration of
LBR-101 is safe and provides migraine prevention in patients with chronic migraine.

Two distinct doses of subcutaneous LBR-101 administered monthly will be compared to placebo
for safety and efficacy. The mean change from baseline in the number of cumulative headache
hours measured at the 28-day period ending with week 12.

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.

- Chronic migraine meeting the diagnostic criteria listed in the International
Classification of Headache Disorders (ICHD-III beta version, 2013)

- 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
headache data on a minimum of 22/28 days (80% diary compliance)

Exclusion Criteria:

- Onset of chronic migraine after the age of 50 years.

- 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 6 months prior to
study entry.

- Subject is using 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.
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53
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Boulder, Colorado
1174
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Ann Arbor, Michigan
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Arlington, TX
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Atlanta, GA
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Bristol, Tennessee
237
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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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Canton, OH
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Charlottesville, Virginia
278
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Cincinnati, Ohio
98
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127
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Cleveland, OH
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Columbus, Ohio
1
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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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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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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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Jacksonville, Florida
670
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Kalamazoo, Michigan
208
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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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Long Beach, California
1977
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788
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Maitland, FL
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Memphis, Tennessee
508
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Mount Pleasant, South Carolina
525
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Nashville, Tennessee
332
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New Bedford, Massachusetts
642
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Oceanside, California
1949
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Oklahoma City, Oklahoma
849
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746
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Philadelphia, Pennsylvania
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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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Reno, NV
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Roanoke, Virginia
249
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Saint Louis, Missouri
394
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San Francisco, California
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Scottsdale, Arizona
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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
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Walnut Creek, California
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Watertown, Massachusetts
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Winston-Salem, North Carolina 27103
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Worcester, Massachusetts
604
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