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