| Participants |
202 patients, 37 withdrew due to adverse effects. 10 in placebo group, 12 in tolcapone 100 mg tid group, and 15 in tolcapone 200 mg tid group.
139 males. Mean age 64 years, mean disease duration 10.9 years, mean levodopa dose 867 mg/day.
Inclusion criteria: At least 30 years old, had two of the three cardinal features of PD, and were clinically diagnosed with idiopathic PD. Patients had to have been treated with levodopa for at least 1 year and shown clear improvement with levodopa therapy. Patients had to be receiving at least 4 doses of the standard levodopa/carbidopa ($/1) preparation or , if CR formulation was used, at least 3 daily intakes, of which at least two were CR. Patients had to have predictable motor fluctuations at the end of the dosing interval that could not be eliminated by adjusting existing antiparkinsonian medications.
Exclusion criteria: Non‐idiopathic parkinsonism, sudden unpredictable 'off/on' fluctuations or disabling diphasic dyskinesias, a MMSE score of 25 or less, and treatment with centrally acting dopamine antagonists during the previous 6 months or MAOI (other than selegiline) during previous 2 months. |
