NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Parkinson's disease
Date of first enrollment	04/10/2016
Target sample size	150
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : KW-6356 INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material : oral administration control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : oral administration

Outcome(s)

Primary Outcome	Change from baseline in the MDS-UPDRS partIII score 12-week evaluation
Secondary Outcome	Change from baseline in the MDS-UPDRS subitem and total scores 12-week evaluation CGI-I score 12-week evaluation PGI-I score 12-week evaluation Change from baseline in PDQ-39 total scores 12-week evaluation Safety 14-week evaluation Pharmacokinetics 12-week evaluation

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 80age old
Gender	Both
Include 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 partIII score of >= 15
Exclude 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 specifided 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 subinvestigator including those who are unable to communicate or to cooperate with the investigator or subinvestigator.