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NEUROLOGY 1998;50:S39-S45
© 1998 American Academy of Neurology

Tolcapone in stable Parkinson's disease

Efficacy and safety of long-term treatment

C. H. Waters, MD, M. Kurth, MD, PhD, P. Bailey, MD, L. M. Shulman, MD, P. LeWitt, MD, E. Dorflinger, MD, D. Deptula, PhD, S. Pedder, PhD and Tolcapone Stable Study Group

From the University of Southern California, Los Angeles, CA (Dr. Waters); Barrow Neurological Institute, Phoenix, AZ (Dr. Kurth); St John Regional Hospital, St John, New Brunswick (Dr. Bailey); University of Miami School of Medicine, Miami, FL (Dr. Shulman); Sinai Clinical Neuroscience Research Center, West Bloomfield, MI (Dr. LeWitt); and Hoffmann-La Roche, Nutley, NJ (Drs. Dorflinger, Deptula, and Pedder).

Address correspondence and reprint requests to Dr Waters, University of Southern California School of Medicine, Division of Movement Disorders, 1510 San Pablo Street #615, Los Angeles, CA 90033.

Abstract.

In this double-blind, placebo-controlled trial, we investigated the effect of the catechol-O-methyltransferase inhibitor tolcapone 100 or 200 mg three times daily on activities of daily living and motor function in 298 patients with parkinsonism receiving levodopa but without motor fluctuations. At 6 months, both dosages of tolcapone produced significant reductions in the Unified Parkinson's Disease Rating Scale scores for activities of daily living (Subscale II) and motor function (Subscale III) and in the total score for Subscales I to III. These improvements were maintained up to the 12-month assessment. At 6 months, both tolcapone groups had changes in levodopa dosage that were significantly different from placebo: the tolcapone groups had decreases in mean total daily dose of levodopa, whereas the placebo group had a mean increase. Tolcapone was well tolerated. The principal adverse events were levodopa-related, but these were generally mild or moderate. Diarrhea was the most frequent nondopaminergic adverse event. Tolcapone appears to be beneficial in the treatment of patients with parkinsonism who have not yet developed motor fluctuations.

Footnotes

Reprinted from Neurology 1997; 49:665-671, with permission.

See Appendix for members of the Tolcapone Stable Study Group.

Supported by F. Hoffman-La Roche Ltd., Basel, Switzerland.

Presented in part at the 48th annual meeting of the American Academy of Neurology, San Francisco, March, 1996.

Received December 27, 1996. Accepted in final form April 10, 1997.






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