evodopa in EArly Parkinson?s disease: a prospective, randomized, double-blind, placebo-controlled, delayed start trial

Academic Medical Center (AMC) (Netherlands)0 个研究点目标入组 445 人开始时间: 2011年8月25日最近更新: 2022年10月31日

适应症

试验速览

•1. Iidiopathic Parkinson's disease (PD) with bradykinesia and at least two of the following signs:
•1.1. Resting tremor
•1.2. Rigidity
•1.3. Asymmetry
•2. Newly diagnosed PD within the past two years
•3. Age 30 years and over
•4. A life expectancy of more than two years
•5. No limitations in functional health for which the patient needs PD-medication

•1. Tremor as most prominent symptom, such as:
•1.1. A severe resting tremor that is present (almost) continuously
•1.2. Tremor of medium to large amplitude which results in functional disability (such as
•interfering with feeding)
•2. Previous treatment with PD-medication, e.g., levodopa, dopamine agonist (DA), monoamine oxidase (MAO)-B-inhibitor, catechol-Omethyl transferase-inhibitor (COMT-inhibitor), or amantadine
•3. Cognitive impairments, i.e., Mini Mental State Examination (MMSE) of 23 points or lower;
•4. More than 28 points on the Beck Depression Scale II (BDI-II)
•5. Diagnosis of depression by a psychiatrist in the last year
•6. History of psychosis
•7. History of glaucoma
•8. The presence of signs indicating atypical or secondary parkinsonism such as:
•8.1. The use of drugs that may cause parkinsonism (e.g., metoclopramide, cinarizine, anti-
•psychotics, natrium-valproate, lithium, amiodarone)
•8.2. Metabolic disorders (e.g., Wilson?s disease)
•8.3. Encephalitis
•8.4. Vascular parkinsonism
•8.5. Repeated head-trauma
•9. Alcohol abuse
•10. Legally incompetent adults
•11. Inability to provide written informed consent

发起方

Academic Medical Center (AMC) (Netherlands)