Parkinson Disease
Conditions
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.
Interventions
DRUGKDT-3594
oral administration, dose titration
DRUGPramipexole
ER formulation, oral administration, dose titration
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 |
|---|---|---|
| Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score | 12 weeks | Change from baseline (Week 0) in MDS-UPDRS total score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score | 12 weeks | Change from baseline (Week 0) in PDQ-39 summary index score |
| Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score | 12 weeks | Change from baseline (Week 0) in PDSS-2 total score |
Countries
Japan
Outcome results
None listed