Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Patients will be randomised to 40 weeks treatment with levodopa / carbidopa 100 / 25 mg three times a day (TID) (including 2 weeks of dose escalation) or 40 weeks placebo TID (phase 1).
Sponsors
Academic Medical Center (AMC) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the mean total Unified Parkinson's Disease Rating Scale (UPDRS) scores between the early and delayed groups at 80 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/04/2016: 1. The progression of symptoms between Visit 2 and Visit 4 (phase 1) and between Visit 5 and Visit 8 (phase 2) measured with the UPDRS: 1.1. Progression in Phase 1: Superiority of the UPDRS slope during phase 1 of the early group as compared to the delayed group 1.2. Progression in Phase 2: Non-inferiority of the UPDRS slope in phase 2 of the early group as compared to the delayed group 2. Disability measured with the AMC Linear Disability Scale (ALDS); The difference between the early group and the delayed group in median change scores (change score = difference between baseline and 80 weeks assessment score) of the ALDS-score. The ALDS is a flexible and feasible instrument to assess the level of disability in patients with newly diagnosed PD 3. Between-group difference in mean total UPDRS scores at 80 weeks and the progression of UPDRS scores during phases 1 and 2 in patients who followed the study ‘per protocol’ 4. Between-group difference in mean total UPDRS scores at 80 weeks and the progression of UPDRS scores during phases 1 and 2 in patients with UPDRS scores in the highest quartile of scores at baseline who followed the study ‘per protocol’ 5. Number of patients that need additional medication for PD 6. Cognitive impairment, measured with the MMSE 7. Depression, measured with the BDI-II 8. Perceived quality of life measured with the PDQ-39 9. Quality Adjusted Life Years (QALY), after applying existing scoring algorithm to derive health utilities from observed European Quality of Life-5 Dimensions (EQ-5D) data 10. Working status and absence from paid work measured with a standardized questionnaire 11. Caregiver burden with a standardized questionnaire 12. Resource utilisation outside o | — |
Countries
Netherlands
Outcome results
None listed