An Early Phase 2 Study of KW-6356 in Subject with Early Parkinson's Disease.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223340

Enrollment

150

Registered

2016-10-04

Start date

2016-10-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

investigational material(s) Generic name etc : KW-6356 INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material

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 1 to 3 on the Modified Hoehn and Yahr Scale -MDS-UPDRS partIII score of >= 15

Exclusion 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 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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in the MDS-UPDRS partIII score 12-week evaluation	—

Secondary

Measure	Time frame
Change from baseline in the MDS-UPDRS subitem and total scores 12-week evaluation CGI-I score 12-week evaluation PGI-I score 12-week evaluation Change from baseline in PDQ-39 total scores 12-week evaluation Safety 14-week evaluation Pharmacokinetics 12-week evaluation	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026