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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 March 2021 |
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Main ID: |
NCT03845387 |
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Date of registration:
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15/02/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
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Scientific title:
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A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease. |
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Date of first enrolment:
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February 26, 2019 |
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Target sample size:
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74 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03845387 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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Naomi Koshihara |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kissei Pharmaceutical Co., Ltd. |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
79 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: KDT-3594
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Drug: Pramipexole
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Primary Outcome(s)
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Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
[Time Frame: 12 weeks]
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Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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