Clinical Trial Ceftriaxone in Subjects With ALS



Status:Archived
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:7/1/2011

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Clinical Trial Ceftriaxone in Subjects With Amyotrophic Lateral Sclerosis (ALS)


The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in
amyotrophic lateral sclerosis (ALS).


It is known that nerve cells called motor neurons die in the brains and spinal cords of
people with amyotrophic lateral sclerosis (ALS). However, the cause of this cell death is
unknown. Researchers think that increased levels of a chemical called "glutamate" may be
related to the cell death. For this reason researchers want to study drugs that decrease
glutamate levels near nerves. Ceftriaxone—a semi-synthetic, third generation cephalosporin
antibiotic—may increase the level of a protein that decreases glutamate levels near nerves.
Studies of ceftriaxone in the laboratory suggest that it may protect motor neurons from
injury.

Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating
bacterial infections but not for treating ALS. Also, ceftriaxone has not been given to
people over a long period of time, such as months or years. The goals of this study are to
evaluate the safety and effectiveness of ceftriaxone as a treatment for ALS, and to
determine the safety and effectiveness of long-term use of the drug in people with ALS.

A total of 600 eligible people with ALS will be enrolled in this multi-center research
study. Participants will be randomly assigned to receive treatment with ceftriaxone (2/3 of
participants) or placebo (1/3 of participants) for at least 12 months.

The study consists of three stages. The first stage, which has completed enrollment, will
look at whether ceftriaxone enters the cerebrospinal fluid (the fluid that surrounds the
spinal cord, also called CSF) in amounts that are high enough to be of possible benefit.
The second stage, which has also completed enrollment, will look at the safety and side
effects of the study drug when taken daily for at least 20 weeks. The study is currently
enrolling subjects for the third stage, which began in Spring 2009, and will determine
whether the study drug prolongs survival and slows decline in function due to ALS.


We found this trial at
51
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Winston-Salem, North Carolina 26157
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43 New Scotland Avenue
Albany, New York 12208
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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6301 Gaston Avenue
Dallas, Texas 75214
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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4500 San Pablo Road
Jacksonville, Florida 32224
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1240 North Mission Road # L919
Los Angeles, California 90033
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701 Park Avenue
Minneapolis, Minnesota 55404
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2150 Corbin Avenue
New Britain, Connecticut 06053
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New York, New York 10021
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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5090 N 40th St # 250
Phoenix, Arizona 85018
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Pittsburgh, Pennsylvania 15212
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
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Atlanta, Georgia 30322
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
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Boston, Massachusetts 02215
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Burlington, Maine 01805
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Charlotte, North Carolina 28207
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Charlottesville, Virginia 22903
(434) 924-0311
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Cleveland, Ohio 44195
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Grand Rapids, Michigan 49503
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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Indianapolis, Indiana 46202
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Lexington, Kentucky 40536
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Lincoln, Nebraska 68506
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Loma Linda, California 92354
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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New Brunswick, New Jersey 08901
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722 W 168th St
New York, New York 10032
(212) 305-2500
Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
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Orange, California 92868
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Portland, Oregon 97213
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Salt Lake City, Utah 84132
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San Francisco, California 94115
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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St. Louis, Missouri 63110
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford university Hospital and Clinics Throughout our history, we have pioneered medical advances that save...
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Ventura, California 93003
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Washington, Washington DC 20052
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