Study Purpose:
The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis , ALS
Study Type:
Interventional
Type of Intervention:
Drug, N/A
Intervention Name:
ceftriaxone, placebo
Placebo:
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, MSc., Associate Professor of Neurology, Harvard Medical School, Massachusetts General Hospital
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Massachusetts General Hospital
149 13th Street
Charlestown, Massachusetts, 02129 United States
Full Study Summary:
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.
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.
Study Sponsor:
Massachusetts General Hospital
Participant Duration:
52 weeks after last subject is enrolled.
Estimated Enrollment:
513
Estimated Study Start Date:
05 / 31 / 2009
Estimated Study Completion Date:
11 / 01 / 2012
Posting Last Modified Date:
04 / 21 / 2014
Date Study Added to neals.org:
07 / 07 / 2006
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria:- Participants will be people with ALS, at least 18 years of age.
- Participants must be medically able to undergo the study procedures and have a caregiver or other individual who will be available to help with daily study medication administration.
- Participants should live within a reasonable distance of the study site, due to frequent study visits.
Exclusion Criteria:
- Participants cannot be taking any other experimental medications for ALS, or have a history of sensitivity to cephalosporin antibiotics (such as Ancef, Keflex, Ceclor, Ceftin, Lorabid, Suprax, or Fortaz).
Phoenix Neurological Associates
Phoenix, Arizona
85018
United States
University of California, Davis
Davis, California
95819
United States
University of California, San Francisco- Fresno
Fresno, California
93701
United States
Loma Linda University School of Medicine (CA)
Loma Linda, California
92354
United States
Cedars-Sinai Medical Center
Los Angeles, California
90048
United States
University of California, Los Angeles
Los Angeles, California
90095
United States
University of California, Irvine - MDA ALS Neuromuscular Center
Orange, California
92868
United States
California Pacific Medical Center
San Francisco, California
94115
United States
University of California, San Francisco
San Francisco, California
94117
United States
University of Colorado Health Sciences Center
Aurora, Colorado
80045
United States
Hospital for Special Care
New Britain, Connecticut
06053
United States
George Washington University
Washington, District of Columbia
20037
United States
Mayo Clinic Jacksonville
Jacksonville, Florida
32224
United States
University of Miami School of Medicine
Miami, Florida
33136
United States
ALS Center at Emory University
Atlanta, Georgia
30322
United States
Medical College of Georgia
Augusta, Georgia
30912
United States
Northwestern University Medical School
Chicago, Illinois
60611
United States
Indiana University (Regenstrief Health Center)
Indianapolis, Indiana
46202
United States
University of Kansas Medical Center
Kansas City, Kansas
66161
United States
University of Kentucky Medical Center
Lexington, Kentucky
40536
United States
Massachusetts General Hospital
Boston, Massachusetts
02114
United States
Lahey Clinic
Burlington, Massachusetts
01805
United States
Henry Ford Health System
Detroit, Michigan
48202
United States
Saint Mary's Healthcare
Grand Rapids, Michigan
49503
United States
Hennepin County Medical Center (Berman Center)
Minneapolis, Minnesota
55404
United States
St. Louis University
St. Louis, Missouri
63104
United States
Washington University
St. Louis, Missouri
63110
United States
Bryan LGH Medical Center (University of Nebraska)
Lincoln, Nebraska
68506
United States
UMDNJ- Robert Wood Johnson School of Medicine
New Brunswick, New Jersey
08901
United States
Albany Medical Center
Albany, New York
12208
United States
Beth Israel Medical Center (NY)
New York, New York
10003
United States
Cornell Medical Center
New York, New York
10021
United States
Columbia University
New York, New York
10032
United States
SUNY Upstate Medical University
Syracuse, New York
13210
United States
Carolinas Medical Center
Charlotte, North Carolina
28203
United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina
27157
United States
The Cleveland Clinic Foundation
Cleveland, Ohio
44195
United States
Ohio State University
Columbus, Ohio
43210
United States
Oregon Clinic (Providence Clinic)
Portland, Oregon
97213
United States
Pennsylvania State University, Hershey Medical Center
Hershey, Pennsylvania
17033
United States
Drexel University College of Medicine (Hahnemann Campus)
Philadelphia, Pennsylvania
19107
United States
University of Pennsylvania
Philadelphia, Pennsylvania
19107
United States
Allegheny Hospital
Pittsburgh, Pennsylvania
15212
United States
University of Pittsburgh
Pittsburgh, Pennsylvania
15213
United States
Medical University of South Carolina
Charleston, South Carolina
29403
United States
Vanderbilt University
Nashville, Tennessee
37232
United States
Texas Neurology
Dallas, Texas
75214
United States
Methodist Neurological Institute
Houston, Texas
77030
United States
University of Utah Health Sciences Center
Salt Lake City, Utah
84132
United States
University of Virginia
Charlottesville, Virginia
22908
United States
University of Calgary
Calgary, Alberta
T2N 4Z6
Canada
Univeristy of Alberta ALS Clinic
Edmonton, Alberta
T6G 2B7
Canada
Dalhousie University
Halifax, Nova Scotia
Canada
London Health Sciences Center, University Campus
London, Ontario
Canada
University of Toronto
Toronto, Ontario
Canada
CHUM (Centre Hospitalier de l'Université de Montréal), Notre-Dame Hospital
Montreal, Quebec
Canada
Montreal Neurological Institute (McGill University)
Montreal, Quebec
Canada
Laval University
Quebec City, Quebec
Canada