A Study of KW-6356 in Patients With Parkinson's Disease o... | NCT03703570

NCT03703570

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KW-6356 Low Dose	Experimental	Oral administration	Drug: KW-6356
KW-6356 High Dose	Experimental	Oral administration	Drug: KW-6356
placebo	Placebo Comparator	Oral administration	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
KW-6356	Drug	Oral administration	KW-6356 High Dose KW-6356 Low Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III score	MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).	Up to 26 weeks after dosing

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state)		Up to 26 weeks after dosing

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria.
Parkinson's disease patients in Stages 2 to 4 on the Modified Hoehn and Yahr Scale. (mH&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon)
MDS-UPDRS partIII score of >= 15. (Evaluation at ON state)
Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment.
Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment.

Exclusion Criteria:

Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection
Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment.
Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife)
Subject who have received administration of adenosine A2A receptor antagonist.
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 subinvestigator including those who are unable to communicate or to cooperate with the investigator or subinvestigator.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases