Monotherapy of Parkinson's disease with budipine - A randomised double-blind comparision to amantadine

In a randomised double blind parallel-group study in three centers budipine , a diphenylpiperidin derivate, was compared to amantadine with respect to efficacy and safety in the monotherapy of mild to moderate Parkinson's dise ase (PD). From 53 patients of either sex 27 patients were randomised to 3 x 20 mg/d budipine and 26 patients to 3 x 100 mg/d amantadine. The duration of treatment was 4 weeks in 1 center(21 patients) and 12 weeks in the other 2 centers (32 patients). Safety was measured by vital signs, ECC, adverse event recording and clinical laboratory. Both drugs caused a clinically rel evant and statistically significant (p<0.001) improvement of Parkinsonian s ymptoms according to the Webster-Rating-Scale (WRS) as compared to pretreat ment values. With respect to the total WRS score sum there was no differenc e betweeen the groups (p>0.05; n.s.), while budipine showed a significantly (p<0.05) better effect on the main symptom tremor after 12 weeks. During a mantadine treatment more adverse events were observed than after budipine i ntake. Two patients left the study prematurely, one in the amantadine group due to psychiatric adverse events and one in the budipine group because of insufficient efficacy.