Parkinson Disease
Conditions
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.
Interventions
DRUGKDT-3594
oral administration, dose titration
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 8 weeks | Change from baseline (Week 0) in MDS-UPDRS total score |
Countries
Japan
Outcome results
None listed