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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: KW-6356; Drug: Placebo

• Registration Number: NCT02939391
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Primary Completion: 2017-11-22
• Study Completion: 2017-12-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KW-6356 Low Dose	KW-6356	Oral administration
Placebo	Placebo	Oral administration
KW-6356 High Dose	KW-6356	Oral administration

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Change from baseline in the MDS-UPDRS subitem and 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