Parkinson Disease
Conditions
Brief summary
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
Interventions
DRUGBI-Sifrol®
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®) 2. Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks 3. Male or female patients aged 20 and over 4. In or out-patients 5. Patient's severity characterized as Stage 1 - 5 by Modified Hoehn & Yahr scale 6. 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
1. History of hypersensitivity of pramipexole 2. Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior 3. Subjective symptom derived from orthostatic hypotension 4. Hypotension (systolic blood pressure; 100 mmHg or less) 5. Complication such as clinically significant cardiac, renal and hepatic diseases 6. Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities 7. Pregnant, possibly pregnant or female in lactation 8. Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study 9. Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who prematurely discontinued due to adverse event | up to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Clinical global impression (CGI) of efficacy | up to 12 weeks | — |
| Number of patients with adverse events | up to 12 weeks | — |
| Number of patients with abnormal changes in laboratory parameters | up to 12 weeks | — |
| Change of Modified Hoehn & Yahr scale | up to 12 weeks | — |
| Number of patients with clinically significant changes in vital signs | up to 12 weeks | Blood Pressure, Pulse Rate |
| Change of the sum of UPDRS Part III (motor examination) | up to 12 weeks | — |
| Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) | up to 12 weeks | — |
| Number of patients with clinically significant changes in electrocardiogram (ECG) | up to 12 weeks | — |
Outcome results
None listed