A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations

Recruitment & Eligibility

Status: completed

Sex: All

Target Recruitment: 486

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Change from baseline in the MDS-UPDRS partIII score<br>26-week evaluation

Secondary Outcome Measures

Name	Time	Method
efficacy<br>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)<br><br>26-week evaluation<br>safety<br>26-week evaluation<br>pharmacokinetics<br>26-week evaluation

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