ATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT

nità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase0 个研究点开始时间: 2013年3月15日最近更新: 2016年1月18日

适应症

试验速览

暂无简介。

•-Age =70 years
•-Idiopathic PD confirmed by at least two of the following signs: resting tremor, bradikynesia, rigidity
•-Diagnosis of PD within the last 12 months and onset of symptoms within 12 months from diagnosis
•-Disease stage I or II according to Hoehn and Yahr Scale
•-Ability to provide written informed consent
•-Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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 80

•-Disease duration more than 12 months since diagnosis and/or duration of symptoms at diagnosis for more than 12 months
•-Hoehn & Yahr stage =3
•-Atypical or secondary parkinsonism
•-Patient currently on L-dopa, DA or other PD medication at baseline
•-Centrally acting dopaminergic agents, MAOIs, tolcapone, budipine, neuroleptics taken within the 28 days preceding the baseline visit
•-History of deep brain stimulation
•-History of severe cardiac disease/heart failure in the last 3 years
•-History of repeated falls
•-History of sulfite sensitivity
•-Arterial hypotension
•-Stroke or a transient ischemic attack within the last 12 months
•-Previous or current treatment with rotigotine (at any time)
•-Diagnosis of dementia according to DSM-IV-R
•-Mini mental State Examination (MMSE) total score <24 at screening visit
•-History of psychosis
•- Clinically relevant hepatic dysfunction and/or transaminase levels 5+ times higher than upper normal value
•-Experimental treatments within the antecedent 3 months
•-History of drug or alcohol dependency
•-Poor compliance with treatment
•-Inability to comply with protocol

发起方

nità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase