Amyotrophic lateral sclerosis (ALS) is a disease of the motor nerves. The motor nerves are the nerves that tell your muscles to work. In ALS, these nerves become damaged, they degenerate and then gradually die. This causes progressive weakness of the muscles. Any muscle that you can voluntarily control can become weak. The cause(s) of ALS are unknown, although much has been learned about it in the past 10 years and more is being discovered.
ALS is characterized by rapid progressive motor dysfunction and paralysis, leading to death within three to five years after diagnosis, with a median survival of 18 months. There is only one drug, Aventis Pharmaceuticals' Rilutek, approved for the treatment of ALS. Rilutek, approved in 1995, inhibits presynaptic glutamate release. Its effect is extremely modest, offering patients an average of three months' life extension.
CEFTRIAXONE
What is ceftriaxone, and how may it help ALS patients?
This trial is the culmination of drug screening program aimed at finding better treatment for diseases such as ALS. Ceftriaxone is an intravenously administered antibiotic approved for certain infections but has additional properties that give it promise for ALS. The drug screening effort found an unexpected action on glutamate, a messenger used by nerve cells. It suggested that ceftriaxone may slow the progression of ALS through its glutamate-regulating properties. Rilutek®, the only FDA-approved medication for ALS, is also a glutamate regulator.
What is the ceftriaxone study?
This is a multicenter, phase II, double-blind, placebo-controlled study. It involves placement of a central line catheter and twice daily infusion of medication. Participants are required to make frequent visits (weekly for the first four weeks and then monthly for the duration of the trial) to our center secondary to the aggressive nature of this study and the potential for serious side effects. Participants will be assessed with muscle testing, breathing capacity tests and functional rating scales to determine the potential efficacy of Ceftriaxone. Some of the criteria for participation in this study include:
- ALS disease duration of three years or less
- Breathing capacity of 60 percent or better
- No BiPap use
- Must live within convenient travel range from our center
- No sensitivity or recent exposure to cephalosporin medications
Contact Us
PLEASE NOTE:
To be involved in the neuromuscular drug trials, you must be evaluated and followed at the Methodist Neurological Institute MDA/ALS Clinical Center.
For more information about this study, please contact:
Sharon L. Halton, MSW, LCSW
Senior Research Coordinator
Phone: 713-441-3420
Fax: 713-793-7271
E-mail: SLHalton@tmhs.org
Luis F. Lay, Jr., MD
Senior Research Coordinator
Phone: 713-441-3057
Fax: 713-793-7271
E-mail: LFLayJr@tmhs.org
