Pilot Co-Q10
Enrollment Closed
The Eleanor and Lou Gehrig ALS Center at Columbia University conducted a clinical trial of Co-Q10 enzyme in ALS. The purpose of the study, "Open Label Study of efficacy with Co-Q10- enzyme in ALS," is to determine the effectiveness of the Co-Q10 enzyme in the treatment of ALS. The study began in spring 1999 and enrollment has been completed.
As of July 31, 2001
RESULTS: Of the 16 patients originally enrolled, nine patients completed the study, with one patient still outstanding. Two patients withdrew from the study. Three patients expired while on the study, and two of these had Motor Unit Number Estimate (MUNE) decline in 6 patients over 5 months was less than the 50% seen in the natural history of ALS. In the same 6 patients, ALS Functional Rating Scores (ALSFRS) declined from 0 - 25%. Decline in strength from baseline over 9 months was approximately 6% for completers. Slow vital capacity (SVC) declined approximately 10 % in completers. CoQ10 was well tolerated and demonstrated no adverse effects on any major organ systems.
CONCLUSION: The therapeutic benefit of high doses of CO-Q-10 was difficult to assess in an open-label study with a small sample size. However, the positive trends seen in the completers strongly justify a larger double blind study of CoQ10 in ALS. Drug for this study was supplied through the generosity of Solgar Laboratories, Inc., Leonia, N.J., USA
PURPOSE: To determine effectiveness of the Co-Q10 antioxidant in the treatment of ALS.
OPENING/CLOSING DATES: Began March 1999
TARGET NUMBER OF PARTICIPANTS: 25
RECRUITMENT STATUS: Closed
