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Stalevo in Early Wearing-Off Patients (SEWOP)

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ClinicalTrials.gov Identifier: NCT00125567
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : June 22, 2009
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

July 29, 2005
August 1, 2005
June 22, 2009
August 2005
March 2009   (Final data collection date for primary outcome measure)
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms [ Time Frame: Up to 2 years of treatment ]
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms.
Complete list of historical versions of study NCT00125567 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Unified Parkinson's Disease Rating Scale
  • Clinical Global Impression of Change (investigator)
  • Parkinson's Disease Questionnaire (PDQ-39)
  • Work Impairment Questionnaire
Not Provided
Not Provided
 
Stalevo in Early Wearing-Off Patients
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
  • 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
  • Experimental: 1
    Stalevo (levodopa/carbidopa/entacapone)
    Intervention: Drug: Stalevo (levodopa/carbidopa/entacapone)
  • Active Comparator: 2
    Levodopa/carbidopa
    Intervention: Drug: Levodopa/carbidopa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
223
244
March 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Germany,   Ireland,   Sweden,   United Kingdom
 
 
NCT00125567
2939111
EudraCT number: 2004-005234-39
No
Not Provided
Not Provided
Andrew Wighton, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Study Director: Andrew Wighton, BSc (Hons) Orion Corporation, Orion Pharma
Principal Investigator: Bhadravati SD Sastry, FRCP University Hospital of Wales and Rookwood Hospital
Orion Corporation, Orion Pharma
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP