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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939391
• Other study ID #: 6356-002
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2016
• Last updated: March 19, 2018
• Start date: September 2016
• Est. completion date: December 8, 2017

Study information

• Verified date: March 2018
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 8, 2017
• Est. primary completion date: November 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• KW-6356
Oral administration
• KW-6356
Oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part? score		Up to 12 weeks after dosing
Secondary	Clinical global impression-improvement(CGI-I) score		Week 12
Secondary	Patient global impression-improvement(PGI-I) score		Week 12
Secondary	Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores		Up to 12 weeks after dosing
Secondary	Number and percentage of subjects with treatment-emergent adverse events		Up to 14 weeks after dosing
Secondary	Profiles of pharmacokinetics of plasma KHK6356 concentration		2, 4, 8 and 12 weeks after dosing
Secondary	Change from baseline in the MDS-UPDRS subitem and total scores		Up to 12 weeks after dosing