Back to resultsA Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KDT-3594
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KDT-3594
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of adverse events
The numbers of events and subjects, the incidence regarding adverse events.
Plasma concentrations of KDT-3594 and its metabolites
Plasma concentrations of KDT-3594 and its metabolites during treatment period.
Secondary Outcome Measures
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change from baseline (Week 0) in MDS-UPDRS total score
Full Information
NCT ID
NCT04867551
First Posted
April 27, 2021
Last Updated
May 10, 2022
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04867551
Brief Title
A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
Official Title
A Phase II Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
September 6, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KDT-3594
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KDT-3594
Intervention Description
oral administration, dose titration
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Description
The numbers of events and subjects, the incidence regarding adverse events.
Time Frame
8 weeks
Title
Plasma concentrations of KDT-3594 and its metabolites
Description
Plasma concentrations of KDT-3594 and its metabolites during treatment period.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
Change from baseline (Week 0) in MDS-UPDRS total score
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshitaka Shimizu
Organizational Affiliation
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Multiple Locations
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease
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