Stalevo in Early Wearing-Off Patients
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...
Brief Summary
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”
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: March 2009
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Stalevo (levodopa/carbidopa/entacapone)
- Active Comparator: 2
- Levodopa/carbidopa
Outcome Measures for this Clinical Trial
Primary 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
Safety Issue?: No
- Time Frame: Up to 2 years of treatment
Secondary Measures
- Unified Parkinson's Disease Rating Scale
- Time Frame: Up to 2 years of treatment
Safety Issue?: No
- Time Frame: Up to 2 years of treatment
- Clinical Global Impression of Change (investigator)
- Time Frame: Up to 2 years of treatment
Safety Issue?: No
- Time Frame: Up to 2 years of treatment
- Parkinson's Disease Questionnaire (PDQ-39)
- Time Frame: Up to 2 years of treatment
Safety Issue?: No
- Time Frame: Up to 2 years of treatment
- Work Impairment Questionnaire
- Time Frame: Up to 2 years of treatment
Safety Issue?: No
- Time Frame: Up to 2 years of treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Orion Corporation, Orion Pharma Industry
Overall Clinical Trial Officials and Contacts
Andrew Wighton, BSc (Hons) Study Director Orion Corporation, Orion Pharma
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00125567
Study ID Number: 2939111
ClinicalTrials.gov Identifier: NCT00125567
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00125567
