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Tolcapone improves motor function in parkinsonian patients with the"wearing-off" phenomenon

A double-blind, placebo-controlled, multicenter trial

From the Division of Neurology (Dr. Rajput), Royal University Hospital, Saskatoon, Saskatchewan, Canada; Division of Neurology (Dr. Martin), University of Alberta, Edmonton, Alberta, Canada; the Neurological Referral Center (Dr. Saint-Hilaire), Boston University School of Medicine, Boston, MA; and Hoffmann-La Roche (Drs. Dorflinger and Pedder), Nutley, NJ.

Address correspondence and reprint requests to Dr Rajput, Division of Neurology, Room 1663, Royal University Hospital, College Drive, Saskatoon, Saskatchewan, Canada S7N OW8.

Abstract.

We studied the new catechol-O-methyltransferase inhibitor tolcapone, 100 and 200 mg, three times daily (tid) in a randomized, double-blind, parallel-group trial involving 202 parkinsonian patients who were experiencing the "wearing-off" phenomenon on levodopa therapy. After 3 months, patients receiving tolcapone had a significant decrease in mean daily levodopa dose requirement compared with placebo-treated patients (p< 0.01). In patients treated with tolcapone 200 mg tid, daily "off" time, measured using patient diaries, was reduced from baseline by 3.25 hours; this reduction was significantly different from that seen in the placebo group(p < 0.01). Moreover, the number of daily levodopa intakes was reduced significantly in each tolcapone group compared with placebo(p < 0.01). We found significant improvements in motor function and overall efficacy in the tolcapone groups (p < 0.01). The most frequent adverse events were associated with levodopa treatment. Dyskinesia developed or worsened in 18% of patients receiving placebo, in 51% receiving tolcapone 100 mg tid, and in 64% receiving 200 mg tid, with most cases occurring within the first 30 days of the study. Diarrhea was the most frequent nondopaminergic event, occurring in 14% on placebo, 13% on tolcapone 100 mg tid, and 19% on 200 mg tid. Overall 18% of patients withdrew because of adverse events: 15% on placebo, 17% on tolcapone 100 mg tid, and 22% on 200 mg tid. We conclude that tolcapone as an adjunct offers promise for the relief of the "wearing-off" phenomenon in levodopa-treated parkinsonian patients.

Footnotes

Reprinted from Neurology 1997; 49:1066-1071, with permission.

See Appendix for names of principal investigators.

Supported by Hoffmann-La Roche Ltd, Basel, Switzerland.

Received February 20, 1997. Accepted in final form April 21, 1997.