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OpenTrials
Completed

NCT Number: NCT02231905

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI-Sifrol®

Drug

Primary outcomes

  1. Number of patients who prematurely discontinued due to adverse event

    Time frame: up to 12 weeks

Secondary outcomes

  1. Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)

    Time frame: up to 12 weeks

  2. Change of the sum of UPDRS Part III (motor examination)

    Time frame: up to 12 weeks

  3. Change of Modified Hoehn & Yahr scale

    Time frame: up to 12 weeks

  4. Change of Clinical global impression (CGI) of efficacy

    Time frame: up to 12 weeks

  5. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to 12 weeks

  6. Number of patients with clinically significant changes in vital signs

    Time frame: up to 12 weeks

    Blood Pressure, Pulse Rate

  7. Number of patients with adverse events

    Time frame: up to 12 weeks

  8. Number of patients with clinically significant changes in electrocardiogram (ECG)

    Time frame: up to 12 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
First posted
Sep 4, 2014
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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