Efficacy and tolerability of Comtess® versus Cabaseril® as add-on to levodopa in the treatment of Parkinsonian patients suffering from wearing- off phenomenon - CAMP

Orion Pharma GmbH0 个研究点目标入组 300 人开始时间: 2004年10月11日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-male and female patients suffering from idiopathic Parkinson's Disease (PD) with wearing-off phenomenon
•-age over 60 years
•-OFF-time per day over 60 min after the first ON-period in the morning
•-3-5 daily dosages of standard levodopa/DDC inhibitor
•-stable antiparkinsonian treatment 3 weeks prior to the randomisation
•-written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-symptomatic parkinsonism
•-concomitant treatment with non-selective MAO inhibitors or a selective MAO-A inhibitor while treated with a MAO-B inhibitor already
•-concomitant treatment with one of the following catechol-structured drugs: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine or apomorphine
•-concomitant treatment with alpha-methyldopa, reserpine, typical or atypical neuroleptics, neuroleptic antiemetics (such as metoclo-pramide) or other drugs with antidopaminergic action
•-treatment with COMT-inhibitors or dopamine agonists 4 weeks prior to the randomisation
•-known hypersensitivity to ergot derivatives and entacapone
•-any clinically significant concurrent illness that may influence the outcome of the study or is contraindicatedtreatment with any investigational drug within the last 3 months prior to randomisation

发起方