A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease

Kissei Pharmaceutical Co., Ltd.7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

KDT-3594DRUG

oral administration, dose titration

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Multiple Locations, Japan

Outcomes

Primary Outcomes

Occurrence of adverse events

The numbers of events and subjects, the incidence regarding adverse events.

Time frame: 8 weeks

Plasma concentrations of KDT-3594 and its metabolites

Plasma concentrations of KDT-3594 and its metabolites during treatment period.

Time frame: 8 weeks

Secondary Outcomes

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Change from baseline (Week 0) in MDS-UPDRS total score

Time frame: 8 weeks

Data from ClinicalTrials.gov

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