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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703570
• Other study ID #: 6356-003
• Status: Completed
• Phase: Phase 2
• Start date: September 29, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: September 2020
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• 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 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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Japan	Iwamizawa Neurology Clinic	Iwamizawa	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa 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 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).	Up to 26 weeks after dosing
Secondary	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