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

NCT ID: NCT02231905

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BI-Sifrol®

Intervention Type: DRUG

Interventions

BI-Sifrol®

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

248.544

Identifier Type: -

Identifier Source: org_study_id