A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
- Registration Number
- NCT04867551
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KDT-3594 KDT-3594 -
- Primary Outcome Measures
Name Time Method Occurrence of adverse events 8 weeks The numbers of events and subjects, the incidence regarding adverse events.
Plasma concentrations of KDT-3594 and its metabolites 8 weeks Plasma concentrations of KDT-3594 and its metabolites during treatment period.
- Secondary Outcome Measures
Name Time Method Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 8 weeks Change from baseline (Week 0) in MDS-UPDRS total score
Trial Locations
- Locations (1)
Research Site
🇯🇵Multiple Locations, Japan