Status:
COMPLETED
Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Parkinson Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02231905
Start Date
January 1 2004
Last Update
September 4 2014
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