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Clinical Trials/NCT00125567
NCT00125567
Completed
Phase 4

Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off

Orion Corporation, Orion Pharma19 sites in 6 countries223 target enrollmentAugust 2005
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ConditionsIdiopathic Parkinson's Disease
InterventionsStalevo (levodopa/carbidopa/entacapone)Levodopa/carbidopa
DrugsStalevo (levodopa/carbidopa/entacapone)Levodopa/carbidopa

Overview

Phase
Phase 4
Intervention
Stalevo (levodopa/carbidopa/entacapone)
Conditions
Idiopathic Parkinson's Disease
Sponsor
Orion Corporation, Orion Pharma
Enrollment
223
Locations
19
Primary Endpoint
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.

Registry
clinicaltrials.gov
Start Date
August 2005
End Date
March 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Idiopathic Parkinson's disease
  • •Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
  • •Unchanged antiparkinsonian medication for 6 weeks prior to baseline

Exclusion Criteria

  • •Secondary or atypical parkinsonism
  • •Patients with daily unpredictable OFF periods or painful dyskinesia

Arms & Interventions

1

Stalevo (levodopa/carbidopa/entacapone)

Intervention: Stalevo (levodopa/carbidopa/entacapone)

2

Levodopa/carbidopa

Intervention: Levodopa/carbidopa

Outcomes

Primary Outcomes

The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms

Time Frame: Up to 2 years of treatment

Secondary Outcomes

  • Parkinson's Disease Questionnaire (PDQ-39)(Up to 2 years of treatment)
  • Work Impairment Questionnaire(Up to 2 years of treatment)
  • Unified Parkinson's Disease Rating Scale(Up to 2 years of treatment)
  • Clinical Global Impression of Change (investigator)(Up to 2 years of treatment)

Study Sites (19)

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