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The Tolcapone Fluctuator Study Group I*.
*See page 87 for members of the Tolcapone Fluctuator Study Group I.
From the Section of Movement Disorders (Dr. Kurth), Barrow Neurological Institute, Phoenix, AZ; Department of Neurology (Dr. Adler), Mayo Clinic, Scottsdale, AZ; Department of Neurology (Dr. St. Hilaire), Boston University, Boston, MA; Department of Neurology (Dr. Singer), University of Miami, Miami, FL; Department of Neurology (Dr. Waters), University of Southern California, Los Angeles, CA; Sinai Hospital of Detroit (Dr. LeWitt), Detroit, MI; and Hoffmann-LaRoche (Drs. Dorflinger and Yoo), Nutley, NJ.
This study was designed and funded by Hoffmann-LaRoche, Nutley, NJ.
Received February 12, 1996. Accepted in final form June 5, 1996.
Address correspondence and reprint requests to Dr. Kurth, Barrow Neurological Institute, Section of Movement Disorders, 222 West Thomas, Suite 401, Phoenix, AZ 85013.
Tolcapone is a potent catechol-O-methyltransferase inhibitor that prolongs the plasma half-life of levodopa. This multicenter, double-blind, placebo-controlled study used two 10-hour clinical evaluations to compare the efficacy and safety of three doses of tolcapone (50, 200, and 400 mg tid) with placebo in patients with Parkinson's disease (PD) experiencing motor fluctuations from levodopa/carbidopa. One hundred fifty-one patients completed the study. Clinical evaluations lasting 10 hours were performed on day -1 and day 42 using United Parkinson's Disease Rating Scale motor subscale and "on/off" and dyskinesia assessments every 30 minutes. Tolcapone significantly reduced "off" time an average of 40% and increased total "on" time by about 25% at all dose levels, as compared to placebo treatment. Levodopa/carbidopa dosage and frequency were significantly reduced. Tolcapone was well tolerated, with patients experiencing typical dopaminergic side effects that could be reduced or eliminated by lowering levodopa/carbidopa dosages. Tolcapone was effective at prolonging the clinical benefit of levodopa and reducing total levodopa requirements in PD patients with motor fluctuations.
NEUROLOGY 1997;48: 81-87
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