A Study of KW-6356 in Subjects With Early Parkinson's Disease

• Status: Completed
• Trial end date: 2017-12-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

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.