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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KW-6356
KW-6356
Placebo
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

KW-6356 Low Dose

KW-6356 High Dose

Placebo

Arm Description

Oral administration

Oral administration

Oral administration

Outcomes

Primary Outcome Measures

Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score

Secondary Outcome Measures

Clinical global impression-improvement(CGI-I) score
Patient global impression-improvement(PGI-I) score
Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores
Number and percentage of subjects with treatment-emergent adverse events
Profiles of pharmacokinetics of plasma KHK6356 concentration
Change from baseline in the MDS-UPDRS subitem and total scores

Full Information

First Posted
October 17, 2016
Last Updated
March 19, 2018
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02939391
Brief Title
A Study of KW-6356 in Subjects With Early Parkinson's Disease
Official Title
An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KW-6356 Low Dose
Arm Type
Experimental
Arm Description
Oral administration
Arm Title
KW-6356 High Dose
Arm Type
Experimental
Arm Description
Oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
KW-6356
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
KW-6356
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
Time Frame
Up to 12 weeks after dosing
Secondary Outcome Measure Information:
Title
Clinical global impression-improvement(CGI-I) score
Time Frame
Week 12
Title
Patient global impression-improvement(PGI-I) score
Time Frame
Week 12
Title
Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores
Time Frame
Up to 12 weeks after dosing
Title
Number and percentage of subjects with treatment-emergent adverse events
Time Frame
Up to 14 weeks after dosing
Title
Profiles of pharmacokinetics of plasma KHK6356 concentration
Time Frame
2, 4, 8 and 12 weeks after dosing
Title
Change from baseline in the MDS-UPDRS subitem and total scores
Time Frame
Up to 12 weeks after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Asahikawa City
State/Province
Hokkaido
Country
Japan
City
Akashi
State/Province
Hyogo
Country
Japan
City
Fujisawa
State/Province
Kanagawa
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Nakano
State/Province
Tokyo
Country
Japan
City
Setagaya
State/Province
Tokyo
Country
Japan
City
Kyoto
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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