Clinical Trial Ceftriaxone in Subjects With ALS
3 other identifiers
interventional
513
2 countries
58
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2006
Longer than P75 for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 5, 2006
CompletedFirst Posted
Study publicly available on registry
July 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
April 1, 2014
CompletedApril 21, 2014
April 1, 2014
6.3 years
July 5, 2006
October 23, 2013
April 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Survival
Survival is presented as median day of survival for each group. Survival is defined as time to death, tracheostomy or the initiation of permanent assisted ventilation (PAV).
From date of randomization until date of death, tracheostomy, or the initiation of permanent assisted ventilation (PAV). This was assessed at time of each participant's drug discontinuation and every 2 months thereafter for the life of the study (6 yrs)
Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year
Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised (ALSFRS-R) is a quickly administered (five minute) ordinal rating scale used to determine patients' assessment of their capability and independence in 12 functional activities/questions. The 12 functional activities/questions are rated on a scale of 0 to 4 for a total scoring range of 0-48, with 48 representing optimal function. All 12 activities are relevant in ALS. This outcome measure calculation is based on measurements every 8 weeks from the Baseline Visit up until one year.
Every 8 weeks for one year
Secondary Outcomes (4)
Change in % Vital Capacity From Screening to One Year
Every 12 weeks for one Year
Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year
Every 12 weeks for one Year
Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year
Every 12 weeks for one Year
Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year
Every 12 weeks for one Year
Study Arms (2)
Ceftriaxone
ACTIVE COMPARATORTwo thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving. Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day.
Placebo
PLACEBO COMPARATOROne third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving. Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day.
Interventions
Participants will be randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. Two thirds of participants will receive ceftriaxone and one third will receive placebo. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving. 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
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 D.C., 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
Québec, Quebec, Canada
Related Publications (3)
McDonnell E, Schoenfeld D, Paganoni S, Atassi N. Causal inference methods to study gastric tube use in amyotrophic lateral sclerosis. Neurology. 2017 Oct 3;89(14):1483-1489. doi: 10.1212/WNL.0000000000004534. Epub 2017 Sep 1.
PMID: 28864675DERIVEDCudkowicz ME, Titus S, Kearney M, Yu H, Sherman A, Schoenfeld D, Hayden D, Shui A, Brooks B, Conwit R, Felsenstein D, Greenblatt DJ, Keroack M, Kissel JT, Miller R, Rosenfeld J, Rothstein JD, Simpson E, Tolkoff-Rubin N, Zinman L, Shefner JM; Ceftriaxone Study Investigators. Safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis: a multi-stage, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014 Nov;13(11):1083-1091. doi: 10.1016/S1474-4422(14)70222-4. Epub 2014 Oct 5.
PMID: 25297012DERIVEDBerry JD, Shefner JM, Conwit R, Schoenfeld D, Keroack M, Felsenstein D, Krivickas L, David WS, Vriesendorp F, Pestronk A, Caress JB, Katz J, Simpson E, Rosenfeld J, Pascuzzi R, Glass J, Rezania K, Rothstein JD, Greenblatt DJ, Cudkowicz ME; Northeast ALS Consortium. Design and initial results of a multi-phase randomized trial of ceftriaxone in amyotrophic lateral sclerosis. PLoS One. 2013 Apr 17;8(4):e61177. doi: 10.1371/journal.pone.0061177. Print 2013.
PMID: 23613806DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merit Cudkowicz
- Organization
- MGH
Study Officials
- PRINCIPAL INVESTIGATOR
Merit Cudkowicz, MD, MSc.
Associate Professor of Neurology, Harvard Medical School, Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
July 5, 2006
First Posted
July 7, 2006
Study Start
July 1, 2006
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
April 21, 2014
Results First Posted
April 1, 2014
Record last verified: 2014-04