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Stalevo in Early Wearing-Off Patients

NCT00125567 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2009-06-22

No results posted yet for this 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.

Conditions

  • Idiopathic Parkinson's Disease

Interventions

DRUG

Stalevo (levodopa/carbidopa/entacapone)

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

DRUG

Levodopa/carbidopa

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

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Andrew Wighton, BSc (Hons) · Orion Corporation, Orion Pharma

  • Bhadravati SD Sastry, FRCP · University Hospital of Wales and Rookwood Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Denmark
  • Finland
  • Germany
  • Ireland
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125567 on ClinicalTrials.gov