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Stalevo in Early Wearing-Off Patients (SEWOP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125567
First Posted: August 1, 2005
Last Update Posted: June 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Orion Corporation, Orion Pharma
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale [ Time Frame: Up to 2 years of treatment ]
  • Clinical Global Impression of Change (investigator) [ Time Frame: Up to 2 years of treatment ]
  • Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Up to 2 years of treatment ]
  • Work Impairment Questionnaire [ Time Frame: Up to 2 years of treatment ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Andrew Wighton, Orion Pharma
ClinicalTrials.gov Identifier: NCT00125567     History of Changes
Other Study ID Numbers: 2939111
EudraCT number: 2004-005234-39
First Submitted: July 29, 2005
First Posted: August 1, 2005
Last Update Posted: June 22, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Entacapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors