A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
The primary objective of this study is to determine the recommended dose and evaluate the
 effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the
 change from baseline in Movement disorder society-unified Parkinson's disease rating
 scale(MDS-UPDRS) partIII score between KW-6356 and placebo in patients with Parkinson's
 disease on treatment with Levodopa-containing preparations as an adjunctive therapy.
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.