In order to objectively quantify the tremorlytic activity of
budipine in
Parkinson'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 completed 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 improved. Fourteen patients who enrolled in a multicenter, double-blind, placebo-controlled study underwent longterm
tremor analysis in addition to the Columbia University Rating Scale (CURS).
Tremor occurrence was improved in the
budipine 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 latter result was statistically not significant, probably due to the small patient 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 improvement in the placebo group (from 7.1 to 5.5). These data suggest that
budipine is an effective tremorlytic agent in PD, which may be used as an alternative to
anticholinergics.