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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
BI-Sifrol®
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BI-Sifrol®

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of patients who prematurely discontinued due to adverse event

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 3, 2014
    Last Updated
    September 3, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02231905
    Brief Title
    Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease
    Official Title
    Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BI-Sifrol®
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    BI-Sifrol®
    Primary Outcome Measure Information:
    Title
    Number of patients who prematurely discontinued due to adverse event
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)
    Time Frame
    up to 12 weeks
    Title
    Change of the sum of UPDRS Part III (motor examination)
    Time Frame
    up to 12 weeks
    Title
    Change of Modified Hoehn & Yahr scale
    Time Frame
    up to 12 weeks
    Title
    Change of Clinical global impression (CGI) of efficacy
    Time Frame
    up to 12 weeks
    Title
    Number of patients with abnormal changes in laboratory parameters
    Time Frame
    up to 12 weeks
    Title
    Number of patients with clinically significant changes in vital signs
    Description
    Blood Pressure, Pulse Rate
    Time Frame
    up to 12 weeks
    Title
    Number of patients with adverse events
    Time Frame
    up to 12 weeks
    Title
    Number of patients with clinically significant changes in electrocardiogram (ECG)
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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

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