RESEARCH: Clinical Trials

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CLINICAL TRIAL OF CEFTRIAXONE IN SUBJECTS WITH ALS

Study Rational:
It is known that nerve cells called motor neurons die in the brains and spinal cords of people with ALS. However, the cause of the 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 is an antibiotic (in a class known as "cephalosporins") that is approved to treat certain types of infections. The investigators involved in this study are interested in studying ceftriaxone because the drug may also 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 form injury.

Design:

• Primary objective: To determine the pharmacokinetics, safety, and efficacy of long-term Ceftriaxone treatment in subjects with ALS.
• The study is a placebo-controlled clinical trial and will treat up to 600 research participants with ALS enrolled at 46-50 centers in the US and Canada using a three-step sequential drug development design. Enrollment began in August 2006.
• Medication given twice a day through a central venous catheter placed in the neck therefore a caregiver is required to participate in the study.
• The shortest time to complete the study will be 52 weeks. The longest time to complete the study will be 5 years. Over the 5 years, patients will be asked to make up to 70 office visits.

Eligibility:

• Vital capacity (VC) at least 60% predicted value for gender, height and age at screening.
  
• Women must not be able to become pregnant for the duration of the study.
  
• First ALS symptoms occurred no more than 3 years prior to screening visit.
  
• Not taking riluzole, or on a stable dose for at least thirty days prior to the screening visit.
  
• Medically able to undergo placement of central venous catheter.
  
• Exclusion Criteria:
  
  • Dependence on mechanical ventilation for any part of the day or night prior to the screening visit.
  • History of known sensitivity or intolerability to penicillin.
    
  • Active gastrointestinal disease within 30 days of the screening visit.
    
  • Active biliary disease, including gallstones.