evodopa in early Parkinson?s disease

Not Applicable

Completed

• Conditions: Parkinson's disease; Nervous System Diseases

• Registration Number: ISRCTN30518857
• Lead Sponsor: Academic Medical Center (AMC) (Netherlands)

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26584951 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30673543 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36253105/ (added 18/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-25
• Study Completion: 2017-11-29
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the mean total Unified Parkinson's Disease Rating Scale (UPDRS) scores between the early and delayed groups at 80 weeks