Status:
COMPLETED
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Conditions:
Parkinson Disease
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
Brief Summary
Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.
Eligibility Criteria
Inclusion
- Japanese patients
- Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
- Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
Exclusion
- Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
- Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
- Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score \< 24 points
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2020
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03845387
Start Date
February 26 2019
End Date
February 21 2020
Last Update
February 17 2021
Active Locations (1)
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1
Research Site
Multiple Locations, Japan