A dose-finding study for SPM 962 in advanced Parkinson's disease patients with L-dopa adjunct therapy
- Conditions
- Idiopathic Parkinson's disease
- Registration Number
- JPRN-jRCT2080220282
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
1. Subject diagnosed as having Parkinson's disease in accordance with Diagnostic Criteria established by the Research Committee of MHW-specified Intractable Neurodegenerative Diseases (1995)
2. Aged over 30 years and less than 80 years at the time of informed consent
3. Hoehn & Yahr stage II - IV (on time)
4. Total UPDRS Part III score is over 10 at screening test (on time)
5. Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962
6. Subject has any of the following problematic symptoms
1) Wearing off phenomenon
2) On and off phenomenon
3) Delayed-on and/or No-on phenomenon
4) Not well controlled with L-dopa due to adverse effect
5) Weakening of L-dopa efficacy
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method