Idiopathic Parkinson's Disease
Conditions
Brief 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.
Interventions
DRUGStalevo (levodopa/carbidopa/entacapone)
Oral, 50-150 mg levodopa four times daily, for up to 2 years
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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
* Secondary or atypical parkinsonism * Patients with daily unpredictable OFF periods or painful dyskinesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms | Up to 2 years of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale | Up to 2 years of treatment |
| Clinical Global Impression of Change (investigator) | Up to 2 years of treatment |
| Parkinson's Disease Questionnaire (PDQ-39) | Up to 2 years of treatment |
| Work Impairment Questionnaire | Up to 2 years of treatment |
Countries
Denmark, Finland, Germany, Ireland, Sweden, United Kingdom
Outcome results
None listed