Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release

CASA DI CURA PRIVATA S.RAFFAELE - PISANA0 个研究点开始时间: 2012年4月18日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•A subject will be eligible for inclusion in this study only if all of the following criteria apply: Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages I-IV) Subjects ia a stable DA agonists dose regimen for at least 18 months Subjects provided written informed consent for the study. Subjects are willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1. Late stage advanced subjects demonstrating incapacitating dyskinesias 2. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological (other than Parkinson’s disease), or cardiovascular disease or active malignancy (other than basal cell cancer). 3. Any abnormality, at screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG. 4. Recent history of severe dizziness or fainting due to postural hypotension on standing. 5. Clinical dementia that in the judgment of the investigator would preclude assessment of the subject. 6. Subjects with neurotic behaviour, crippling degenerative arthritis or limb amputations, which would preclude efficacy or safety assessments. 7. Subjects with prior or current major psychosis (e.g. schizophrenia or psychotic depression) e.g., scoring 3 or 4 on UPDRS item 2 (thought disorder) or item 3 (depression). 8. Recent history or current evidence of drug abuse or alcoholism.

发起方

CASA DI CURA PRIVATA S.RAFFAELE - PISANA