Stalevo in Early Wearing-Off Patients

Phase 4

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: Stalevo (levodopa/carbidopa/entacapone); Drug: Levodopa/carbidopa

• Registration Number: NCT00125567
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-07-29
• Study Start: 2005-08
• Study First Posted: 2005-08-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-19
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Stalevo (levodopa/carbidopa/entacapone)	Stalevo (levodopa/carbidopa/entacapone)
2	Levodopa/carbidopa	Levodopa/carbidopa

Primary Outcome Measures

Name	Time	Method
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms	Up to 2 years of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Århus Kommunehospital; 🇩🇰 Nørrebrogade 44, Denmark

South Karelia Central Hospital; 🇫🇮 Lappeenranta, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Parkinson Klinik Bad Nauheim; 🇩🇪 Bad Nauheim, Germany

Neurologische Klinik Bad Neustadt; 🇩🇪 Bad Neustadt, Germany

Neurologische Klinik der Universitat Dusseldorf; 🇩🇪 Duesseldorf, Germany

Allgemeines Krankenhaus Harburg; 🇩🇪 Hamburg, Germany

Praxis Drs Lang, Krauss, Schreiber; 🇩🇪 Ulm, Germany

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