Stalevo in Early Wearing-Off Patients - Full Text View

Sponsor:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00125567

Purpose

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.

Condition	Intervention	Phase
Idiopathic Parkinson's Disease	Drug: Stalevo (levodopa/carbidopa/entacapone) Drug: Levodopa/carbidopa	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa OR 611 Entacapone

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

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 ]

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 ]

Enrollment:	223
Study Start Date:	August 2005
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Stalevo (levodopa/carbidopa/entacapone)	Drug: Stalevo (levodopa/carbidopa/entacapone) Oral, 50-150 mg levodopa four times daily, for up to 2 years
2: Active Comparator Levodopa/carbidopa	Drug: Levodopa/carbidopa Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125567

Locations

Denmark
Århus Kommunehospital
Nørrebrogade 44, Denmark, 8000
Aalborg Hospital
Aalborg, Denmark, DK-9000 Aalborg
Bispebjerg Hospital
Copenhagen, Denmark
Finland
South Karelia Central Hospital
Lappeenranta, Finland
Tampere University Hospital
Tampere, Finland, 33521 Tampere
Germany
Allgemeines Krankenhaus Harburg
Hamburg, Germany, 21075 Hamburg
Neurologische Klinik Bad Neustadt
Bad Neustadt, Germany, 97616 Bad Neustadt
Parkinson Klinik Bad Nauheim
Bad Nauheim, Germany, 61231 Bad Nauheim
Praxis Drs Lang, Krauss, Schreiber
Ulm, Germany, 89073 Ulm
Neurologische Klinik der Universitat Dusseldorf
Duesseldorf, Germany, 40225 Duesseldorf
Ireland
Mater Private Hospital
Dublin, Ireland, Dublin 7
Sweden
Läkarhuset Vällingby
Vällingby, Sweden, SE-162 68
Universitetssjukhuset MAS
Malmö, Sweden, SE-205 02
United Kingdom
Frenchay Hospital
Bristol, United Kingdom, BS16 1LE
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Leigh Infirmary
Leigh, United Kingdom, WN7 1HS
United Kingdom, Surrey
Movement Disorder Services
Chertsey, Surrey, United Kingdom, KT16 0QA
United Kingdom, Wales
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Glan Clwyd Hospital
Rhyl, Wales, United Kingdom, CF14 4XW

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

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

More Information

No publications provided

Responsible Party:	Orion Pharma ( Andrew Wighton )
Study ID Numbers:	2939111, EudraCT number: 2004-005234-39
Study First Received:	July 29, 2005
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00125567 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Ireland: Irish Medicines Board; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Finland: National Agency for Medicines; Lithuania: State Medicine Control Agency - Ministry of Health

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Carbidopa
Central Nervous System Diseases
Antiparkinson Agents
Enzyme Inhibitors

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Entacapone
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009