A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
NCT ID: NCT03845387
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2019-02-26
2020-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KDT-3594
KDT-3594
oral administration, dose titration
Pramipexole
Reference drug
Pramipexole
ER formulation, oral administration, dose titration
Interventions
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KDT-3594
oral administration, dose titration
Pramipexole
ER formulation, oral administration, dose titration
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
79 Years
ALL
No
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Naomi Koshihara
Role: STUDY_DIRECTOR
Kissei Pharmaceutical Co., Ltd.
Locations
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Research Site
Multiple Locations, , Japan
Countries
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Other Identifiers
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KDT1201
Identifier Type: -
Identifier Source: org_study_id
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