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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-12-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KW-6356 Low Dose

Oral administration

Group Type EXPERIMENTAL

KW-6356

Intervention Type DRUG

Oral administration

KW-6356 High Dose

Oral administration

Group Type EXPERIMENTAL

KW-6356

Intervention Type DRUG

Oral administration

Placebo

Oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration

Interventions

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KW-6356

Oral administration

Intervention Type DRUG

KW-6356

Oral administration

Intervention Type DRUG

Placebo

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No