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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: KW-6356; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03703570

6356-003

Details and patient eligibility

About

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.

Enrollment: 502 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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502 participants in 3 patient groups, including a placebo group

KW-6356 Low Dose

Experimental group

Description:

Oral administration

Treatment:

Drug: KW-6356

KW-6356 High Dose

Experimental group

Description:

Oral administration

Treatment:

Drug: KW-6356

placebo

Placebo Comparator group

Description:

Oral administration

Treatment:

Drug: Placebo