The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.
Not Applicable
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-UMIN000024859
- Lead Sponsor
- Medical Corporation Abe Neurology Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who have taken zonisamide within 6 months from the start of study drug administration
2)Patients with cognitive impairment of MMSE score 23 or less
3)Patients who have undergone surgical therapy for parkinsonism, including stereotactic neurosurgery
4)Pregnant or possibly pregnant women, women of childbearing potential who do not agree to use appropriate contraceptive measures, or breast-feeding women
5)Patients who, in the opinion of the investigator or other study personnel, are unsuitable for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the MDS-UPDRS Part III (motor symptoms) total score at 12 weeks and change in the MDS-UPDRS Part 1.2 (hallucinations and psychosis) score at 12 weeks
- Secondary Outcome Measures
Name Time Method 1)Change in the MDS-UPDRS Part1 (non-motor symptoms except Part 1.2) total score, change in the MDS-UPDRS Part 2(motor aspects) total score, and change in the MDS-UPDRS Part 4 (motor complications) total score <br>2)Change in the BDI-2(depression)total score <br>3)Change in the JESS(sleepiness)total score <br>4)Change in the J-ZBI(burden of caregiver) total score <br>5)Change in the NPI(BPSD) total score <br>6)Change in the MMSE(cognitive function)total score