NL-OMON55477
Completed
Phase 4
evodopa in early Parkinson*s disease;LEAP-5Y-study: Follow-up of the Levodopa in early Parkinson's disease study - LEAP-study;LEAP-5Y-study: Acroniem follow-up trial: LEAP-5Y-study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Parkinson's disease
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 446
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The inclusion criteria are:
- •\* idiopathic PD (13\) with bradykinesia and at least two of the following signs:
- •\* resting tremor;
- •\* rigidity;
- •\* asymmetry.
- •\* newly diagnosed PD within the past two years;
- •\* age 30 years and over;
- •\* a life expectancy of more than two years;
- •\* no limitations in functional health for which the patient needs
- •PD\-medication., LEAP\-5Y\-study:
Exclusion Criteria
- •The exclusion criteria are:
- •\* tremor as most prominent symptom, such as (13\):
- •\* a severe resting tremor that is present (almost) continuously;
- •\* tremor of medium to large amplitude which results in functional disability
- •(such as interfering with feeding)
- •\* previous treatment with PD\-medication, e.g., levodopa, DA, MAO\-B\-inhibitor,
- •catechol\-O\-methyl transferase\-inhibitor (COMT\-inhibitor), or amantadine;
- •\* cognitive impairments, i.e., Mini Mental State Examination (MMSE) of 23
- •points or lower (14\);
- •\* more than 28 points on the Beck Depression Scale II (BDI\-II) (15\);
Outcomes
Primary Outcomes
Not specified
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