Stalevo in Early Wearing-Off Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 29, 2005

Last Updated Date

April 20, 2009

Start Date ^†

August 2005

Current Primary Outcome Measures ^†

The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms [ Time Frame: Up to 2 years of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00125567 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Unified Parkinson's Disease Rating Scale [ Time Frame: Up to 2 years of treatment ] [ Designated as safety issue: No ]
Clinical Global Impression of Change (investigator) [ Time Frame: Up to 2 years of treatment ] [ Designated as safety issue: No ]
Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Up to 2 years of treatment ] [ Designated as safety issue: No ]
Work Impairment Questionnaire [ Time Frame: Up to 2 years of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Unified Parkinson's Disease Rating Scale
Clinical Global Impression of Change (investigator)
Parkinson's Disease Questionnaire (PDQ-39)
Work Impairment Questionnaire

Descriptive Information

Brief Title ^†

Stalevo in Early Wearing-Off Patients

Official Title ^†

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

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Idiopathic Parkinson's Disease

Intervention ^†

Drug: Stalevo (levodopa/carbidopa/entacapone)
Drug: Levodopa/carbidopa

Study Arms / Comparison Groups

Experimental: Stalevo (levodopa/carbidopa/entacapone)
Active Comparator: Levodopa/carbidopa

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

244

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark, Finland, Germany, Ireland, Sweden, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00125567

Responsible Party

Andrew Wighton, Orion Pharma

Secondary IDs ^††

EudraCT number: 2004-005234-39

Study Sponsor ^†

Orion Corporation, Orion Pharma

Collaborators ^††

Investigators ^†

Study Director:	Andrew Wighton, BSc (Hons)	Orion Corporation, Orion Pharma
Principal Investigator:	Bhadravati SD Sastry, FRCP	University Hospital of Wales and Rookwood Hospital

Information Provided By

Orion Corporation, Orion Pharma

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.