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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867551
• Other study ID #: KDT1202A
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2021
• Est. completion date: September 6, 2021

Study information

• Verified date: August 2021
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• KDT-3594
oral administration, dose titration

Locations

Country	Name	City	State
Japan	Research Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	The numbers of events and subjects, the incidence regarding adverse events.	8 weeks
Primary	Plasma concentrations of KDT-3594 and its metabolites	Plasma concentrations of KDT-3594 and its metabolites during treatment period.	8 weeks
Secondary	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Change from baseline (Week 0) in MDS-UPDRS total score	8 weeks