Parkinson's Disease
Conditions
Interventions
investigational material(s)
Generic name etc : KW-6356
INN of investigational material : -
Therapeutic category code : 116 Antiperkinsonism agents
Dosage and Administration for Investigational materia
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline in the MDS-UPDRS partIII score 26-week evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 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) 26-week evaluation safety 26-week evaluation pharmacokinetics 26-week evaluation | — |
Countries
Japan
Outcome results
None listed