A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KDT-3594
Pramipexole
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 2
Arm Type
Experimental
Other
Arm Label
KDT-3594
Pramipexole
Arm Description
Reference drug
Outcomes
Primary Outcome Measures
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Change from baseline (Week 0) in MDS-UPDRS total score
Secondary Outcome Measures
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score
Change from baseline (Week 0) in PDQ-39 summary index score
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
Change from baseline (Week 0) in PDSS-2 total score
Full Information
NCT ID
NCT03845387
First Posted
February 15, 2019
Last Updated
February 16, 2021
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03845387
Brief Title
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Official Title
A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
February 21, 2020 (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 efficacy, safety and pharmacokinetics 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KDT-3594
Arm Type
Experimental
Arm Title
Pramipexole
Arm Type
Other
Arm Description
Reference drug
Intervention Type
Drug
Intervention Name(s)
KDT-3594
Intervention Description
oral administration, dose titration
Intervention Type
Drug
Intervention Name(s)
Pramipexole
Intervention Description
ER formulation, oral administration, dose titration
Primary Outcome Measure Information:
Title
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Description
Change from baseline (Week 0) in MDS-UPDRS total score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score
Description
Change from baseline (Week 0) in PDQ-39 summary index score
Time Frame
12 weeks
Title
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
Description
Change from baseline (Week 0) in PDSS-2 total score
Time Frame
12 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
Naomi Koshihara
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
Learn more about this trial
A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
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