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Clinical Trial Ceftriaxone in Subjects With ALS

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ClinicalTrials.gov Identifier: NCT00349622
Recruitment Status : Completed
First Posted : July 7, 2006
Results First Posted : April 1, 2014
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Merit E. Cudkowicz, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Amyotrophic Lateral Sclerosis
ALS
Interventions: Drug: ceftriaxone
Other: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Subjects with ALS were enrolled in 58 institutions across in the US and Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. Two thirds of participants received ceftriaxone and one third received placebo. This is a blinded study, so neither participants nor study staff knew which treatment a participant is receiving.

Reporting Groups
  Description
Ceftriaxone

Two 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

One 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.


Participant Flow:   Overall Study
    Ceftriaxone   Placebo
STARTED   340   173 
COMPLETED   162   77 
NOT COMPLETED   178   96 
Death                168                86 
Lost to Follow-up                5                1 
Withdrawal by Subject                5                9 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Survival   [ Time Frame: 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) ]

2.  Primary:   Change From Baseline in ALS Functional Rating Scale, Revised (ALSFRS-R) at One Year   [ Time Frame: Every 8 weeks for one year ]

3.  Secondary:   Change in % Vital Capacity From Screening to One Year   [ Time Frame: Every 12 weeks for one Year ]

4.  Secondary:   Change From Baseline in Evaluation of Multiple Upper Extremity Muscles Using Hand Held Dynamometry at One Year   [ Time Frame: Every 12 weeks for one Year ]

5.  Secondary:   Change From Baseline in the ALS-Specific Quality of Life Scale (ALSQOL) at One Year   [ Time Frame: Every 12 weeks for one Year ]

6.  Secondary:   Change From Baseline in Evaluation of Multiple Lower Extremity Muscles Using Hand Held Dynamometry at One Year   [ Time Frame: Every 12 weeks for one Year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Merit Cudkowicz
Organization: MGH
phone: 617-724-1873
e-mail: mcudkowicz@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merit E. Cudkowicz, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00349622     History of Changes
Other Study ID Numbers: U01NS049640-02 ( U.S. NIH Grant/Contract )
NINDS ( Other Identifier: NINDS )
U01NS049640-02 ( U.S. NIH Grant/Contract )
NINDS CRC ( Other Identifier: NINDS Clinical Research Collaboration )
First Submitted: July 5, 2006
First Posted: July 7, 2006
Results First Submitted: October 23, 2013
Results First Posted: April 1, 2014
Last Update Posted: April 21, 2014