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

Phase 4

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: BI-Sifrol®

• Registration Number: NCT02231905
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-11
• Status Verified: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-03
• Last Update Submitted: 2014-09-03
• Study First Posted: 2014-09-04
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI-Sifrol®	BI-Sifrol®	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.

Primary Outcome Measures

Name	Time	Method
Number of patients who prematurely discontinued due to adverse event	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
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	up to 12 weeks	Blood Pressure, Pulse Rate
Number of patients with adverse events	up to 12 weeks
Number of patients with clinically significant changes in electrocardiogram (ECG)	up to 12 weeks