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Stalevo in Early Wearing-Off Patients (SEWOP)

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00125567
First received: July 29, 2005
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

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
Experimental: 1
Stalevo (levodopa/carbidopa/entacapone)
 Drug: Stalevo (levodopa/carbidopa/entacapone)
Oral, 50-150 mg levodopa four times daily, for up to 2 years
Active Comparator: 2
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
Aalborg Hospital
Aalborg, Denmark, DK-9000 Aalborg
Bispebjerg Hospital
Copenhagen, Denmark
Århus Kommunehospital
Nørrebrogade 44, Denmark, 8000
Finland
South Karelia Central Hospital
Lappeenranta, Finland
Tampere University Hospital
Tampere, Finland, 33521 Tampere
Germany
Parkinson Klinik Bad Nauheim
Bad Nauheim, Germany, 61231 Bad Nauheim
Neurologische Klinik Bad Neustadt
Bad Neustadt, Germany, 97616 Bad Neustadt
Neurologische Klinik der Universitat Dusseldorf
Duesseldorf, Germany, 40225 Duesseldorf
Allgemeines Krankenhaus Harburg
Hamburg, Germany, 21075 Hamburg
Praxis Drs Lang, Krauss, Schreiber
Ulm, Germany, 89073 Ulm
Ireland
Mater Private Hospital
Dublin, Ireland, Dublin 7
Sweden
Universitetssjukhuset MAS
Malmö, Sweden, SE-205 02
Läkarhuset Vällingby
Vällingby, Sweden, SE-162 68
United Kingdom
Movement Disorder Services
Chertsey, Surrey, United Kingdom, KT16 0QA
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Glan Clwyd Hospital
Rhyl, Wales, United Kingdom, CF14 4XW
Frenchay Hospital
Bristol, United Kingdom, BS16 1LE
Leigh Infirmary
Leigh, United Kingdom, WN7 1HS
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
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: Andrew Wighton, Orion Pharma
ClinicalTrials.gov Identifier: NCT00125567     History of Changes
Other Study ID Numbers: 2939111, EudraCT number: 2004-005234-39
Study First Received: July 29, 2005
Last Updated: June 19, 2009
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: Finnish Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Entacapone
 Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013