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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Notify MeKey information
Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
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
Primary outcomes
-
Number of patients who prematurely discontinued due to adverse event
Time frame: up to 12 weeks
Secondary outcomes
-
Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)
Time frame: up to 12 weeks
-
Change of the sum of UPDRS Part III (motor examination)
Time frame: up to 12 weeks
-
Change of Modified Hoehn & Yahr scale
Time frame: up to 12 weeks
-
Change of Clinical global impression (CGI) of efficacy
Time frame: up to 12 weeks
-
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 12 weeks
-
Number of patients with clinically significant changes in vital signs
Time frame: up to 12 weeks
Blood Pressure, Pulse Rate
-
Number of patients with adverse events
Time frame: up to 12 weeks
-
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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