A Study of KW-6356 in Subjects With Early Parkinson's Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KW-6356 Low Dose Oral administration |
Drug: KW-6356
Oral administration
|
| Experimental: KW-6356 High Dose Oral administration |
Drug: KW-6356
Oral administration
|
| Placebo Comparator: Placebo Oral administration |
Drug: Placebo
Oral administration
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 [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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asahikawa City | Hokkaido | Japan | ||
| 2 | Akashi | Hyogo | Japan | ||
| 3 | Fujisawa | Kanagawa | Japan | ||
| 4 | Suita | Osaka | Japan | ||
| 5 | Nakano | Tokyo | Japan | ||
| 6 | Setagaya | Tokyo | Japan | ||
| 7 | Kyoto | Japan |
Sponsors and Collaborators
- Kyowa Kirin Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6356-002