Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie

CHU de Toulouse0 个研究点目标入组 66 人开始时间: 2010年5月12日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•1. Parkinson’s disease patient, defined by UK Brain Bank criteria
•2. Current age between 30-90
•3. Clinically pertinent dyskinesias defined by CGI-s score (see attachment) > 3 (mild) established by clinician’s total assessment of patient including objective observation during the screening process.
•4. Presence of a caregiver willing to participate in the study
•5. Subjects/caregivers must demonstrate the capacity to complete an accurate home diary based on training and evaluation during the screening period (see attached training rules).
•6. Subjects must be able to provide written informed consent.
•7. In the opinion of the enrolling investigator, the subject will be able to maintain current dosing schedule of antiparkinsonian drugs for the duration of the trial.
•8. The subject must be willing to participate in all study related activities and visits
•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

•1. Documentation of creatinine level at screening evaluation that is not within the normal range for the local university laboratory.
•2. Doses of all antiparkinsonian medications have not been stable for at least 4 weeks
•3. Treatment with amantadine in the last 3 months.
•4. Prior amantadine treatment was stopped due to adverse event.
•5. Prior brain surgery.
•6. Other major illnesses that could be complicated by amantadine exposure, including glaucoma, current hallucinations, urinary retention
•7. Dementia, depression or psychosis.

发起方

CHU de Toulouse