Parkinson's Disease
Conditions
Brief summary
The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.
Interventions
DRUGKW-6356
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion 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 part III score of ≥ 15
Exclusion 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 specified 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 sub-investigator including those who are unable to communicate or to cooperate with the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score | Up to 12 weeks after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Patient global impression-improvement(PGI-I) score | Week 12 |
| Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores | Up to 12 weeks after dosing |
| Clinical global impression-improvement(CGI-I) score | Week 12 |
| Profiles of pharmacokinetics of plasma KHK6356 concentration | 2, 4, 8 and 12 weeks after dosing |
| Change from baseline in the MDS-UPDRS subitem and total scores | Up to 12 weeks after dosing |
| Number and percentage of subjects with treatment-emergent adverse events | Up to 14 weeks after dosing |
Countries
Japan
Outcome results
None listed