In order to objectively quantify the tremorlytic activity of budipine in Pa
rkinson's disease (PD) we performed longterm tremor recordings in a subset
of patients enrolled in two clinical trials.
Eleven PD patients with marked tremor participating in an open-label study
underwent longterm recording before and during medication. Nine patients co
mpleted the study. Tremor occurrence was reduced from 52 +/- 18.6% to 34.7
+/- 19.3% (p < 0.05); tremor intensity decreased from 15.3 +/- 4.8 (SNR) to
11.3 +/- 4.8 (p < 0.01). UPDRS tremor subscores were also significantly im
proved.
Fourteen patients who enrolled in a multicenter, double-blind, placebo-cont
rolled study underwent longterm tremor analysis in addition to the Columbia
University Rating Scale (CURS). Tremor occurrence was improved in the budi
pine group (n = 7) from 24.7 +/- 15.5% to 14.8 +/- 14.5% (p < 0.05). Tremor
intensity decreased from 9.1 +/- 2.5 (SNR) to 7.2 +/- 1.6. However, the la
tter result was statistically not significant, probably due to the small pa
tient number. In the placebo-group (n = 7) there was no reduction of tremor
occurrence or of tremor intensity. The CURS sum score was improved from 5.
7 to 3.0 in the budipine group, whereas there was only a smaller improvemen
t in the placebo group (from 7.1 to 5.5).
These data suggest that budipine is an effective tremorlytic agent in PD, w
hich may by used as an alternative to anticholinergics.