Adjuvant treatment of Parksinson's disease with budipine: a double-blind trial versus placebo.

Budipine, a new 4,4-diphenylpiperidine derivative, and placebo were administered three times daily to 31 patients with Parkinson's disease over a period of 12 weeks. All patients in the two treatment groups received levodopa (plus benserazide) at an optimum and constant dose for at least 2 months before the start of the study and throughout the trial. The additional administration of budipine (daily dose 60 mg) was excellently tolerated by 14 patients, while 2 patients left the study because of mental confusion at an early stage of the trial. The budipine group showed a 22% improvement on the Columbia Rating Scale (median score). Compared with the placebo group (4% improvement), there was a highly significant difference (P less than 0.01, one-tailed test). Of the three main symptoms of Parkinson's disease, the best effect was seen on tremor, and less pronounced effects on bradykinesia and rigidity. Owing to its long half-life (31 h) with little plasma level fluctuations, budipine appears to be an effective agent in the treatment of Parkinson's disease.

RCT Entities:   Population Interventions Outcomes