Status:
COMPLETED
A Clinical Study of KDT-3594 in Japanese 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 safety, pharmacokinetics and efficacy 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 :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04867551
Start Date
May 15 2021
End Date
September 6 2021
Last Update
May 11 2022
Active Locations (1)
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1
Research Site
Multiple Locations, Japan