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Clinical Trials/ISRCTN30518857
ISRCTN30518857
Completed
未知

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

Academic Medical Center (AMC) (Netherlands)0 sites445 target enrollmentAugust 25, 2011
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Academic Medical Center (AMC) (Netherlands)
Enrollment
445
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
August 25, 2011
End Date
November 29, 2017
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Academic Medical Center (AMC) (Netherlands)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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