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

Sponsor

Kyowa Kirin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03703570

Collaborator

(none)

502

Enrollment

Location

Arms

18.5

Actual Duration (Months)

27.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: KW-6356 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

502 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

An interventional, multicenter, randomized, double-blind, placebo-controlled, parallel-group trialAn interventional, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations

Actual Study Start Date :

Sep 29, 2018

Actual Primary Completion Date :

Apr 15, 2020

Actual Study Completion Date :

Apr 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KW-6356 Low Dose Oral administration	Drug: KW-6356 Oral administration
Experimental: KW-6356 High Dose Oral administration	Drug: KW-6356 Oral administration
Placebo Comparator: placebo Oral administration	Drug: Placebo Oral administration

Arm

Intervention/Treatment

Experimental: KW-6356 Low Dose

Oral administration

Drug: KW-6356

Oral administration

Experimental: KW-6356 High Dose

Oral administration

Drug: KW-6356

Oral administration

Placebo Comparator: placebo

Oral administration

Drug: Placebo

Oral administration

Outcome Measures

Primary Outcome Measures

Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III score [Up to 26 weeks after dosing]
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) [Up to 26 weeks after dosing]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iwamizawa Neurology Clinic	Iwamizawa	Hokkaido	Japan

Sponsors and Collaborators

Kyowa Kirin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyowa Kirin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03703570

Other Study ID Numbers:

6356-003

First Posted:

Oct 12, 2018

Last Update Posted:

Sep 7, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Sep 7, 2020