Stalevo in Early Wearing-Off Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

July 29, 2005

Last Updated Date

June 19, 2009

Start Date ^ICMJE

August 2005

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

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

Change History

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

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

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 ^ICMJE

Stalevo in Early Wearing-Off Patients

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Idiopathic Parkinson's Disease

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

223

Completion Date

March 2009

Primary Completion Date

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

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00125567

Responsible Party

Andrew Wighton, Orion Pharma

Study ID Numbers ^ICMJE

2939111, EudraCT number: 2004-005234-39

Study Sponsor ^ICMJE

Orion Corporation, Orion Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

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

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP