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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231905
• Other study ID #: 248.544
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2014
• Last updated: September 3, 2014
• Start date: January 2004

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• BI-Sifrol®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who prematurely discontinued due to adverse event		up to 12 weeks	No
Secondary	Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)		up to 12 weeks	No
Secondary	Change of the sum of UPDRS Part III (motor examination)		up to 12 weeks	No
Secondary	Change of Modified Hoehn & Yahr scale		up to 12 weeks	No
Secondary	Change of Clinical global impression (CGI) of efficacy		up to 12 weeks	No
Secondary	Number of patients with abnormal changes in laboratory parameters		up to 12 weeks	No
Secondary	Number of patients with clinically significant changes in vital signs	Blood Pressure, Pulse Rate	up to 12 weeks	No
Secondary	Number of patients with adverse events		up to 12 weeks	No
Secondary	Number of patients with clinically significant changes in electrocardiogram (ECG)		up to 12 weeks	No

External Links

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