Post-Marketing Clinical Study of ReQuip Tablets in Patients with Parkinson's Disease -Evaluation of Long-Term Efficacy and Safety
- Conditions
- Parkinson's Disease
- Registration Number
- JPRN-jRCT1080220387
- Lead Sponsor
- GlaxoSmithKline K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
Main inclusion criteria:
- Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn & Yahr Stages I to IV.
- Patients who have been receiving another dopamine agonist for at least 4 weeks prior to the start of the screening phase and are expected to benefit from conversion to ReQuip.
- Age: >=20 years (at the time of written informed consent).
Main exclusion criteria:
- Patients who present with any serious medical condition other than PD (e.g., cardiac, hepatic or renal disorder or hematopoietic disorder).
- Patients with postural hypotension with any subjective symptoms (e.g., dizziness and syncope).
- Patients who have had any serious psychiatric symptoms (e.g., confusion, hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD drugs) within 6 months (26 weeks) prior to written informed consent.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method