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A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
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 2 to 4 on the Modified Hoehn and Yahr Scale. (mH&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon)
  • MDS-UPDRS partIII score of >= 15. (Evaluation at ON state)
  • Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment.
  • Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment.

Exclusion Criteria:

  • Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
  • Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection
  • Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment.
  • Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife)
  • Subject who have received administration of adenosine A2A receptor antagonist.
  • 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.

Sites / Locations

  • Iwamizawa Neurology Clinic

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) part III score
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).

Secondary Outcome Measures

Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state)

Full Information

First Posted
October 5, 2018
Last Updated
September 4, 2020
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03703570
Brief Title
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
Official Title
A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 29, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to determine the recommended dose and evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partIII score between KW-6356 and placebo in patients with Parkinson's disease on treatment with Levodopa-containing preparations as an adjunctive therapy.

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
Model Description
An interventional, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
502 (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)
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) part III score
Description
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).
Time Frame
Up to 26 weeks after dosing
Secondary Outcome Measure Information:
Title
Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state)
Time Frame
Up to 26 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 2 to 4 on the Modified Hoehn and Yahr Scale. (mH&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon) MDS-UPDRS partIII score of >= 15. (Evaluation at ON state) Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment. Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment. Exclusion Criteria: Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment. Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment. Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife) Subject who have received administration of adenosine A2A receptor antagonist. 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.
Facility Information:
Facility Name
Iwamizawa Neurology Clinic
City
Iwamizawa
State/Province
Hokkaido
Country
Japan

12. IPD Sharing Statement

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A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations

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