Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT02231905
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02231905
Study Brief:
Protocol Section:
NCT02231905