Alpha‐dihydroergocryptine in Parkinson's disease: a multiceuntre randomized double blind parallel group study

Introduction - A multicentre randomized double-blind parallel group study was carried out on 68 patients suffering from idiopathic Parkinson's disease (PD) treated with l-dopa for at least 1 year with inadequate therapeutic responsiveness. The aim of the study was to compare the efficacy of α-dihydroergocryptine (α-DHEC) vs lisuride as an adjunct therapy to l-dopa on dyskinesias and clinical fluctuations (Unified Parkinson's Disease Rating Scale [UPDRS] part IV), on the symptoms pattern (Columbia University Rating Scale [CURS]), on disability (Northwestern University Disability Scale [NUDS]), and to evaluate the incidence of adverse events. Patients and methods - Thirty-two patients (18 males, 14 females with a mean age of 64.5 ± 1.5 SEM) were randomized to α-dihydroergocryptine and 36 (16 males, 20 females with a mean age of 61.8 ± 1.4) to lisuride. The treatment lasted 3 months and the dosage was increased until it reached 60 mg/day of α-dihydroergocryptine and 1.2 mg/day of lisuride, while the l-dopa dosage was kept constant in both groups. Per protocol and intention to treat analyses were performed on response variables. Results - The adjunctive treatment with the two dopamine agonists determined a significant improvement of PD symptoms in both groups. Alpha-dihydroergocryptine showed a superior efficacy in reducing the clinical complications (P <0.01 by ANOVA). The number of patients complaining of adverse events was 8 out of 32 (25%) for α-dihydroergocryptine and 24/36 (67%) for lisuride (P<0.05). Conclusion - Alpha-dihydroergocryptine effect seems to be superior to that of lisuride both in terms of reduction of l-dopa therapy long term motor complications (UPDRS part IV) as well as in terms of the incidence and severity of adverse events.