Creatine - Clinical Trial Results As a principal Investigator of the Creatine Trial at Columbia 's ALS Research Center , Dr. Hiroshi Mitsumoto shares his communications with Dr. Shefner on the results of the Creatine Trial. “The preliminary results of the trials demonstrated Creatine was safe and well tolerated. However, this trial showed that there wasn't any therapeutic benefit at the dose used. Further analysis is ongoing and we will keep you apprised of the results. At this time you may continue using Creatine if you would like but medically it is not indicated. “ Furthermore, Dr. Mitsumoto and members of the research team extend their ongoing appreciation to the patients and their families for their commitment to further elucidating a cure for ALS by participating in this and other ALS clinical trials. Without their help research cannot move forward. ~ ~ ~ What follows is the official summary released by Jeremy Shefner , MD of the Northeast ALS Coalition of ALS Research on July 28, 2003 after preliminary analysis of the Creatine study data. “ The initial analysis of the creatine/ALS clinical trial has been completed. Although further analysis is ongoing, the major results are clear. Creatine was safe and well tolerated, but our trial showed no hint that there was any therapeutic benefit, at the dose used in this study." In summary: Patient demographics . 104 patients were enrolled in the trial, with 50 patients assigned to the creatine group and 54 patients assigned to placebo. Overall, age was 59 years, baseline weight was 78 kg, and time from symptom onset to screening was approximately 2 years. 62% of patients were male. None of these characteristics varied significantly between placebo and treated groups. The same was true for baseline primary and secondary outcome measures. 2. Efficacy analysis . The primary outcome measure was quantitative muscle testing of the upper extremity. Significant decline in strength was noted in both placebo and creatine treated groups, but there was no significant difference in the rate of progression. Similar findings were observed for grip strength, function, and motor unit number estimate. There were 8 deaths in the study; 6 patients were in the placebo group and 2 in creatine; this difference was not statistically significant. 3. Safety . There were 48 serious adverse events reported. None were attributed as being likely related to study medication. Adverse events were tabulated for body system involved and severity. No adverse event was noted statistically more frequently in the creatine treated patients vs. the control group. 4. Summary . Creatine, at a dose of 5 grams per day, is safe in patients with ALS. However, this study provides no evidence that it is efficacious in any of the outcome measures employed in this study. It is important to note, however, that this study was powered such that there was an 80% chance of detecting a 50% change in the rate of decline of upper extremity muscle strength. Please contact your local ALS Center , MDA or ALS Association office to learn about other ALS Clinical trials in your area.