Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).

Detailed Description
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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 Hypothesis: Comparison(s):

Official Title
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Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Pramipexole 0.125 mg tablets
* Drug: Pramipexole 0.5 mg tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism) (1) Patients meeting all of the following inclusion criteria Patients of at least 20 years of age In- or outpatients of either sex. Patients in any stage on the modified Hoehn and Yahr severity scale Exclusion Criteria: Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour. Patients with subjective symptoms derived from orthostatic hypotension. Patients with hypotension (systolic blood pressure <100 mmHg) Patients with concomitant illness such as severe cardiac, renal, and hepatic disease Patients with a current or past history of epilepsy Pregnant, possibly pregnant, or lactating women Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study. Patients who judged incompetent to give consent Others judged by the investigator or co-investigator to be ineligible as subjects.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pramipexole 0.125 mg tablets|nan|
|Drug: Pramipexole 0.5 mg tablets|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |