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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: KW-6356; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Iwamizawa, Hokkaido, Japan
      • Iwamizawa Neurology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2018
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 6356-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No