Overview

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

Status:
Completed
Trial end date:
2020-02-21
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Treatments:
Pramipexole
Criteria
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