Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00274131|
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : May 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: Pramipexole 0.125 mg tablets Drug: Pramipexole 0.5 mg tablets||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Administration Study of SND 919 Tablets in Parkinson's Disease|
|Study Start Date :||December 1998|
|Estimated Study Completion Date :||February 2004|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274131
|Study Chair:||Boehringer Ingelheim Study Coordinator||Nippon Boehringer Ingelheim Co., Ltd.|