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CompletedNCT00125567SEWOPUpdated Jun 22, 2009

Stalevo in Early Wearing-Off Patients

A Phase 4 interventional study of Stalevo (levodopa/carbidopa/entacapone) and Levodopa/carbidopa in Idiopathic Parkinson's Disease, sponsored by Orion Corporation, Orion Pharma. Completed at 19 sites in 6 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2009-06-22.

Sponsored by Orion Corporation, Orion Pharma · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
223
Allocation
Randomized
Ages
30 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Idiopathic Parkinson's Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 223 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

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Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Secondary or atypical parkinsonism
  • Patients with daily unpredictable OFF periods or painful dyskinesia
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
223 participants (actual)

Study arms

  • Experimental
    1

    Stalevo (levodopa/carbidopa/entacapone)

    Drug: Stalevo (levodopa/carbidopa/entacapone)

  • Active comparator
    2

    Levodopa/carbidopa

    Drug: Levodopa/carbidopa

Interventions

  • DrugStalevo (levodopa/carbidopa/entacapone)

    Oral, 50-150 mg levodopa four times daily, for up to 2 years

  • DrugLevodopa/carbidopa

    Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Unified Parkinson's Disease Rating Scale

    Time frame: Up to 2 years of treatment

  2. Clinical Global Impression of Change (investigator)

    Time frame: Up to 2 years of treatment

  3. Parkinson's Disease Questionnaire (PDQ-39)

    Time frame: Up to 2 years of treatment

  4. Work Impairment Questionnaire

    Time frame: Up to 2 years of treatment

07

Study locations

19 sites
  • Aalborg Hospital
    Aalborg, DK-9000 Aalborg, Denmark
  • Bispebjerg Hospital
    Copenhagen, Denmark
  • Århus Kommunehospital
    Nørrebrogade 44, 8000, Denmark
  • South Karelia Central Hospital
    Lappeenranta, Finland
  • Tampere University Hospital
    Tampere, 33521 Tampere, Finland
  • Parkinson Klinik Bad Nauheim
    Bad Nauheim, 61231 Bad Nauheim, Germany
  • Neurologische Klinik Bad Neustadt
    Bad Neustadt, 97616 Bad Neustadt, Germany
  • Neurologische Klinik der Universitat Dusseldorf
    Duesseldorf, 40225 Duesseldorf, Germany
  • Allgemeines Krankenhaus Harburg
    Hamburg, 21075 Hamburg, Germany
  • Praxis Drs Lang, Krauss, Schreiber
    Ulm, 89073 Ulm, Germany
  • Mater Private Hospital
    Dublin, Dublin 7, Ireland
  • Universitetssjukhuset MAS
    Malmö, SE-205 02, Sweden
  • Läkarhuset Vällingby
    Vällingby, SE-162 68, Sweden
  • Movement Disorder Services
    Chertsey, Surrey KT16 0QA, United Kingdom
  • University Hospital of Wales
    Cardiff, Wales CF14 4XW, United Kingdom
  • Glan Clwyd Hospital
    Rhyl, Wales CF14 4XW, United Kingdom
  • Frenchay Hospital
    Bristol, BS16 1LE, United Kingdom
  • Leigh Infirmary
    Leigh, WN7 1HS, United Kingdom
  • Southampton General Hospital
    Southampton, SO16 6YD, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00125567
Lead sponsor
Orion Corporation, Orion Pharma
First posted
Aug 1, 2005
Start date
Aug 2005
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Jun 22, 2009

Study contacts

Andrew Wighton, BSc (Hons)
study director · Orion Corporation, Orion Pharma
Bhadravati SD Sastry, FRCP
principal investigator · University Hospital of Wales and Rookwood Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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