Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease

Official Title
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Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: BI-Sifrol®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®) Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks Male or female patients aged 20 and over In or out-patients Patient's severity characterized as Stage 1 - 5 by Modified Hoehn & Yahr scale Ability to provide written informed consent in accordance with the Good Clinical Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant laws such as the Pharmaceutical Affairs Law Exclusion Criteria: History of hypersensitivity of pramipexole Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior Subjective symptom derived from orthostatic hypotension Hypotension (systolic blood pressure; 100 mmHg or less) Complication such as clinically significant cardiac, renal and hepatic diseases Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities Pregnant, possibly pregnant or female in lactation Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI-Sifrol®<br>Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks. | Drug: BI-Sifrol®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who prematurely discontinued due to adverse event |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) |  | up to 12 weeks | 
| Change of the sum of UPDRS Part III (motor examination) |  | up to 12 weeks | 
| Change of Modified Hoehn & Yahr scale |  | up to 12 weeks | 
| Change of Clinical global impression (CGI) of efficacy |  | up to 12 weeks | 
| Number of patients with abnormal changes in laboratory parameters |  | up to 12 weeks | 
| Number of patients with clinically significant changes in vital signs | Blood Pressure, Pulse Rate | up to 12 weeks | 
| Number of patients with adverse events |  | up to 12 weeks | 
| Number of patients with clinically significant changes in electrocardiogram (ECG) |  | up to 12 weeks |