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

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ClinicalTrials.gov Identifier: NCT02231905
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: BI-Sifrol® Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole
Study Start Date : January 2004
Actual Primary Completion Date : November 2004

Resource links provided by the National Library of Medicine


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®



Primary Outcome Measures :
  1. Number of patients who prematurely discontinued due to adverse event [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02231905     History of Changes
Other Study ID Numbers: 248.544
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Talipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Antidepressive Agents
Psychotropic Drugs