An Early Phase 2 Study of KW-6356 in Subject with Early Parkinson's Disease.
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2080223340
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 150
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
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in the MDS-UPDRS partIII score<br>12-week evaluation
- Secondary Outcome Measures
Name Time Method Change from baseline in the MDS-UPDRS subitem and total scores<br>12-week evaluation<br>CGI-I score<br>12-week evaluation<br>PGI-I score<br>12-week evaluation<br>Change from baseline in PDQ-39 total scores<br>12-week evaluation<br>Safety<br>14-week evaluation<br>Pharmacokinetics<br>12-week evaluation