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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-6356 Low Dose | Experimental | Oral administration |
|
| KW-6356 High Dose | Experimental | Oral administration |
|
| Placebo | Placebo Comparator | Oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-6356 | Drug | Oral administration |
| |
| KW-6356 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical global impression-improvement(CGI-I) score | Week 12 | |
| Patient global impression-improvement(PGI-I) score | Week 12 | |
| Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores |
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Inclusion Criteria:
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;
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asahikawa | Hokkaido | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37948832 | Derived | Maeda T, Kimura T, Sugiyama K, Yamada K, Hiraiwa R, Nishi M, Hattori N; 6356-002 study group. Randomized controlled trial of KW-6356 monotherapy in patients with early untreated Parkinson's disease. Parkinsonism Relat Disord. 2023 Dec;117:105907. doi: 10.1016/j.parkreldis.2023.105907. Epub 2023 Oct 31. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Drug |
Oral administration |
|
| Placebo | Drug | Oral administration |
|
| Up to 12 weeks after dosing |
| Number and percentage of subjects with treatment-emergent adverse events | Up to 14 weeks after dosing |
| 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 |
| Akashi |
| Hyōgo |
| Japan |
| Fujisawa | Kanagawa | Japan |
| Suita | Osaka | Japan |
| Nakano City | Tokyo | Japan |
| Setagaya City | Tokyo | Japan |
| Kyoto | Japan |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |