A Study of KW-6356 in Subjects With Early Parkinson's Disease

Study Overview
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Brief Summary
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The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.

Official Title
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An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: KW-6356
* Drug: KW-6356
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria Parkinson's disease patients in Stages 1 to 3 on the Modified Hoehn and Yahr Scale MDS-UPDRS part III score of ≥ 15 Exclusion Criteria: Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment. Use of any of the specified antiparkinsonian drugs and dopamine antagonists during the specified period. Treatment with levodopa/DCI at any time in the past for a period of 4 weeks or more. Neurosurgical operation for Parkinson's disease (stereotactic surgery, deep brain stimulation or gamma knife), or treatment by transcranial magnetic stimulation (TMS). Either of the following criteria consecutively at screening and enrollment; Resting Pulse > 100 bpm Resting systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg Significant dementia or a Mini-Mental State Examination (MMSE) score of ≤ 23. Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline. Anyone otherwise considered unsuitable for the study by the investigator or sub-investigator including those who are unable to communicate or to cooperate with the investigator or sub-investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KW-6356 Low Dose<br>Oral administration | Drug: KW-6356<br>* Oral administration<br>|
| Experimental: KW-6356 High Dose<br>Oral administration | Drug: KW-6356<br>* Oral administration<br>|
| Placebo Comparator: Placebo<br>Oral administration | Drug: Placebo<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score |  | Up to 12 weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical global impression-improvement(CGI-I) score |  | Week 12 | 
| Patient global impression-improvement(PGI-I) score |  | Week 12 | 
| Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores |  | Up to 12 weeks after dosing | 
| Number and percentage of subjects with treatment-emergent adverse events |  | Up to 14 weeks after dosing | 
| Profiles of pharmacokinetics of plasma KHK6356 concentration |  | 2, 4, 8 and 12 weeks after dosing | 
| Change from baseline in the MDS-UPDRS subitem and total scores |  | Up to 12 weeks after dosing |