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Tolcapone added to levodopa in stable parkinsonian patients: A double‐blind placebo‐controlled study
Author(s) -
Dupont Erik,
Burgunder JeanMarc,
Findley Leslie J.,
Olsson JanEdvin,
Dorflinger Ernest
Publication year - 1997
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.870120615
Subject(s) - levodopa , placebo , double blind , parkinson's disease , medicine , degenerative disease , anesthesia , physical medicine and rehabilitation , psychology , central nervous system disease , disease , alternative medicine , pathology
Abstract The primary objective of this study was to assess the effect of tolcapone on levodopa dosage in parkinsonian patients whose “wearing‐off” phenomenon has been controlled with more frequent levodopa dosage. After a 1‐week placebo run‐in, 97 patients were assigned randomly to receive placebo or tolcapone 200 or 400 mg three times daily (t.i.d.). Levodopa dosage was reduced by −35% on day 1 of study and subsequently retitrated as required. After 6 weeks, the tolcapone groups crossed over to receive the other dose for a further 3 weeks for exploratory purposes. Both tolcapone groups had greater reductions in levodopa dosage than the placebo group at week 6 (not statistically different). The 200‐mg t.i.d. group showed greatest improvement in estimated mean scores for all efficacy parameters (p < 0.05 versus placebo for change in Unified Parkinson's Disease Rating Scale Subscale II). Fewer dopaminergic and nondopaminergic adverse events were associated with tolcapone 200 mg t.i.d. than with tolcapone 400 mg t.i.d. The most frequently reported dopaminergic adverse events were nausea, cramps, dyskinesia, and dystonia. The most frequently reported unanticipated adverse event was diarrhea. Tolcapone 200 mg t.i.d. may provide additional benefit to patients with moderately advanced Parkinson's disease with treated “wearing‐off” phenomenon.