Post marketing clinical trial of TJ-54
Phase 4
- Conditions
- europsychiatric symptoms of Parkinson`s disease
- Registration Number
- JPRN-jRCT1080220598
- Lead Sponsor
- Tsumura & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
1.Patients with NPI subscale score of 4 points or greater on more than one subscale 4 weeks prior to and at the start of treatment
2.Patients with MMSE (Mini-Mental State Examination) score of 24 points or greater 4 weeks prior to and at the start of treatment
Exclusion Criteria
1.Patients who are diagnosed with dementia based on DSM-IV criteria [Diagnostics and Statistical Manual of Mental Disorders, 4th Edition]
2.Patients with serious complications(heart, liver, or kidney dysfunctions, hematopoietic disorders, malignant tumors, etc.) and other life-threatening diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method