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

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: KW-6356

Study type: Interventional

Funder types: Industry

Identifiers

NCT02939391

6356-002

Details and patient eligibility

About

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.

Enrollment: 175 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 3 patient groups, including a placebo group

KW-6356 Low Dose

Experimental group

Description:

Oral administration

Treatment:

Drug: KW-6356

Drug: KW-6356

KW-6356 High Dose

Experimental group

Description:

Oral administration

Treatment:

Drug: KW-6356

Drug: KW-6356

Placebo

Placebo Comparator group

Description:

Oral administration

Treatment:

Drug: Placebo