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

Kissei Pharmaceutical Co., Ltd.74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

KDT-3594DRUG

oral administration, dose titration

PramipexoleDRUG

ER formulation, 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

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

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

Time frame: 12 weeks

Secondary Outcomes

Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score

Change from baseline (Week 0) in PDQ-39 summary index score

Time frame: 12 weeks

Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score

Change from baseline (Week 0) in PDSS-2 total score

Time frame: 12 weeks

Data from ClinicalTrials.gov

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