A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER STUDY OF PRAMIPEXOLE IN ADVANCED PARKINSONS-DISEASE

Pramipexole (SND 919), a potent non-ergot dopamine agonist, or placebo , was administered to 69 patients with advanced Parkinson's disease (3 3 received placebo, 36 received pramipexole) in a double-blind, random ized, multi-center study in which individually optimized doses of L-do pa plus a dopa decarboxylase inhibitor were associated with dyskinesia , ''on- off'' fluctuation, dystonia, akinesia, or end-of-dose deterior ation. Study medication was titrated over 7 weeks to the maximal toler ated dose or to the maximal dose allowed by the study (5 mg/day in fou r divided doses). Dosing was maintained for 4 weeks and then tapered d uring the final week. Total score on the Unified Parkinson's Disease R ating Scale (UPDRS) for the intent-to-treat population was significant ly improved in the pramipexole-treated group compared with the placebo -treated group (16.9 +/- 14.9 vs 9.0 +/- 16.1; p = 0.0184). By the end of maintenance, the mean reduction in L-dopa requirement was -150.7 m g for pramipexole-treated patients compared to -10.6 for placebo-treat ed patients. The most common adverse events (> 10%) were dizziness, in somnia, nausea, and postural hypotension. Aggravated parkinsonism occu rred only after withdrawal of the study medication. Treatment with pra mipexole in doses up to 5 mg/day was safe and well tolerated by patien ts with advanced Parkinson's disease. (C) 1998 Lippincott-Raven Publis hers.