Parkinson'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria:
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 2)Change in the BDI-2(depression)total score 3)Change in the JESS(sleepiness)total score 4)Change in the J-ZBI(burden of caregiver) total score 5)Change in the NPI(BPSD) total score 6)Change in the MMSE(cognitive function)total score | — |
Countries
Japan
Contacts
EP-CRSU Co. Ltd. (Contract Research Organization) Clinical Research Headquarters