Amyotrophic Lateral Sclerosis Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of creatine treatment
in amyotrophic lateral sclerosis (ALS). There is currently no known effective treatment for
ALS. It is known that nerve cells die in the brains and spinal cords of patients with ALS
but the cause of the cell death is unknown. It has been shown that there is overactive nerve
activity due to increased levels of a chemical called glutamate and that there is abnormal
cellular metabolism along with increased production of substance called "free radicals."
Improving cellular metabolism and readjusting the activity of glutamate in the brain may be
beneficial to ALS patients.
Creatine is a naturally occurring compound, which improves energy metabolism in cells.
Creatine has been given to patients with energy metabolism defects in their muscles, and to
athletes. Creatine improves survival in a mouse model of ALS. Three human subjects with ALS
have received creatine for up to six months without any side effects. Overall, creatine has
been well tolerated and safe.
Half of the subjects in this study will be selected by chance to receive creatine treatment
for 6 months and the other half to receive placebo. Neither the subject nor the investigator
will know which drug the subject is receiving, although this information will be available
in case of emergency. It is anticipated that all subjects will have the choice to receive
creatine after the 6 months study in an open-label study for an additional 12 months. A
total of 114 patients will participate at 15 centers. Approximately 8 subjects will be
enrolled at the Washington University.
The effectiveness of creatine will be determined first by assessing any changes in strength
in the arms and second by changes in grip strength, functional activities, electromyography
changes or changes of the level of SOH 2'dG in the urine.
;
Primary Purpose: Treatment
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