Alpha-dihydroergocryptine in the treatment of de novo parkinsonian patients: results of a multicentre, randomized, double-blind, placebo-controlled study

Introduction - A multicentre, randomized, double-blind, placebo-controlled, parallel group study was carried out in 123 patients suffering from never treated (de nose) idiopathic Parkinson's disease (PD). The aim of the study was to confirm the efficiency and safety of alpha-dihydroergocryptine (alp ha-DHEC) given as monotherapy in the symptomatic treatment of PD. The total score of the Unified Parkinson's Disease Rating Scale (UPDRS) was identifi ed as the efficacy target variable. Patients and methods - Sixty-two patien ts (32 males, 30 females, mean age +/- SD 64 +/- 10) were randomized to alp ha-dihydroergocryptine and 61 (30 males, 31 females, mean age 63.8 +/- 9.1) to placebo. According to the experimental design, a 18-month double-blind phase vs placebo was followed. Two interim analyses were planned both at th e 3rd and 12th month of treatment, in order to avoid continuation on placeb o, if clear differences between groups were found (stopping criterium: nomi nal significance level equal to 0.022 in the analysis of the target variabl e). Analysis of variance was performed both on the per protocol (PP) and in tent-to-treat (ITT) sample. Results - The results on the first interim anal ysis showed significant differences between treatment groups of the UPDRS t otal score both in the ITT (115 patients, alpha-DHEC: No. 56; placebo: No. 59; P=0.019) and PP (96 patients, alpha-DHEC: No. 46; placebo: No. 50, P=0. 001) sample, why the trial was stopped. At the time of stopping the trial, 73 patients (alpha-DPIEC: No. 37; placebo: No. 36) had reached the 6-month observation visit; the analysis carried out on this subset of patients conf irmed the efficacy of alpha-dihydroergocryptine in early PD and the correct ness of the decision to stop. The incidence of adverse drug reactions (ADR) did not differ between a-dihydroergocryptine and placebo recipients, gastr ointestinal complaints being the most frequent. Conclusion - The results in dicate that alpha-dihydroergocryptine is safe and effective in improving sy mptoms of np novo parkinsonian patients.