Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).
Drug: Pramipexole 0.125 mg tablets
Drug: Pramipexole 0.5 mg tablets
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Long-term Administration Study of SND 919 Tablets in Parkinson's Disease|
- UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
- UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy
|Study Start Date:||December 1998|
|Estimated Study Completion Date:||February 2004|
The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper).
The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks).