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

September 3, 2014 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: BI-Sifrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who prematurely discontinued due to adverse event
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)
Time Frame: up to 12 weeks
up to 12 weeks
Change of the sum of UPDRS Part III (motor examination)
Time Frame: up to 12 weeks
up to 12 weeks
Change of Modified Hoehn & Yahr scale
Time Frame: up to 12 weeks
up to 12 weeks
Change of Clinical global impression (CGI) of efficacy
Time Frame: up to 12 weeks
up to 12 weeks
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 12 weeks
up to 12 weeks
Number of patients with clinically significant changes in vital signs
Time Frame: up to 12 weeks
Blood Pressure, Pulse Rate
up to 12 weeks
Number of patients with adverse events
Time Frame: up to 12 weeks
up to 12 weeks
Number of patients with clinically significant changes in electrocardiogram (ECG)
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 4, 2014

Last Update Submitted That Met QC Criteria

September 3, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on BI-Sifrol®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe