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Clinical Trial for Ceftriaxone in Subjects with ALS

 
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS
Study Category:
Drug Trial
Study Status:
Closed
Study Results:
In July 2012, the DSMB for the NINDS-sponsored clinical trial of ceftriaxone in ALS recommended that based on existing data the trial be stopped because the study was unlikely to reach the pre-determined efficacy criteria. The NINDS leadership concurred. Pre-clinical research identified ceftriaxone as a promising treatment for ALS therefore it was important for people with ALS to find out if the drug could be beneficial in ameliorating the disease. The study used a novel seamless adaptive design. Final analysis and presentation of the results will occur after completion of site monitoring and database lock. The important contributions of patients, their families and the hard work of the investigators and their teams made it possible to implement the trial. While all had hoped for a more positive result, the trial has moved ALS research forward.
Phase:
Phase III
Type:
Interventional Trial
with active agents/drugs & a placebo
Funding Source:
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz MD, MSc (Massachusetts General Hospital)
Clinicaltrials.gov ID:
NCT00349622
Study ID:
CEF-ALS-2006
NEALS Affiliated?
Yes
Study Summary:
Ceftriaxone is an antibiotic that in the laboratory has been shown to protect motor neurons from a variety of different types of injury. The clinical trial will determine whether ceftriaxone is effective in ALS and its long term safety. A total of 500 eligible people with ALS will be enrolled. 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. There are 60 study sites enrolling patients in the United States and Canada. Study visits occur every 4 weeks, more frequently during the first month of the study.
Participant Duration:
52 weeks after last subject is enrolled.
# of Subjects:
500
Enrollment Start Date:
06/01/2009
Enrollment End Date:
11/01/2011
Posting Last Modified Date:
11/01/2011
Date Study Added to alsconsortium.org:
10/15/2011
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Min Vital Capacity (% predicted normal):
60%
Time since Symptom Onset:
Less than 36 months
Can participants use Riluzole?
Yes
Coordinating Center
Contact Information
Sarah Titus
stitus@partners.org
(617) 726-1398
Massachusetts General Hospital
149 13th Street
Charlestown, Massachusetts 02129
UNITED STATES
Other Eligibility Criteria:
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. 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).

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