Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
- Registration Number
- NCT02248220
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 657
Inclusion Criteria
- Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated
Exclusion Criteria
- NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinson's disease patients Pramipexole -
- Primary Outcome Measures
Name Time Method Change in cumulative daily doses of Sifrol® up to 8 weeks Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
Changes in cumulative daily doses of L-dopa up to 8 weeks Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
- Secondary Outcome Measures
Name Time Method Global assessment of efficacy by investigator on a 5-point scale after 8 weeks Number of patients with adverse drug reactions up to 8 weeks Change from Baseline in SPES subscales Baseline, after 8 weeks Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy
Change from Baseline in global Parkinson's Disease (PD) symptoms Baseline, after 8 weeks Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor
Global assessment of tolerability by investigator on a 5-point scale after 8 weeks Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score Baseline, after 8 weeks Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score Baseline, after 8 weeks patients with SPES depression \>= 2
Number of patients with adverse events up to 8 weeks Change from Baseline in Tremor Impact Scale (TIS-D) total score Baseline, after 8 weeks