Stalevo in Early Wearing-Off Patients (SEWOP)

June 19, 2009 updated by: Orion Corporation, Orion Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
Time Frame: Up to 2 years of treatment
Up to 2 years of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 29, 2005

First Submitted That Met QC Criteria

July 29, 2005

First Posted (ESTIMATE)

August 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2009

Last Update Submitted That Met QC Criteria

June 19, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2939111
  • EudraCT number: 2004-005234-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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