Clinical trial NCT02231905: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of patients who prematurely discontinued due to adverse event
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)
timeFrame: up to 12 weeks
measure: Change of the sum of UPDRS Part III (motor examination)
timeFrame: up to 12 weeks
measure: Change of Modified Hoehn & Yahr scale
timeFrame: up to 12 weeks
measure: Change of Clinical global impression (CGI) of efficacy
timeFrame: up to 12 weeks
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: up to 12 weeks
measure: Number of patients with clinically significant changes in vital signs
timeFrame: up to 12 weeks
measure: Number of patients with adverse events
timeFrame: up to 12 weeks
measure: Number of patients with clinically significant changes in electrocardiogram (ECG)
timeFrame: up to 12 weeks
Other outcomes:
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