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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02939391
• Date of registration: 17/10/2016
• Prospective Registration: No
• Primary sponsor: Kyowa Kirin Co., Ltd.
• Public title: A Study of KW-6356 in Subjects With Early Parkinson's Disease
• Scientific title: An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease
• Date of first enrolment: September 2016
• Target sample size: 175
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02939391
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: KW-6356

Drug: Placebo

Primary Outcome(s)

Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part? score [Time Frame: Up to 12 weeks after dosing]

Secondary Outcome(s)

Clinical global impression-improvement(CGI-I) score [Time Frame: Week 12]

Number and percentage of subjects with treatment-emergent adverse events [Time Frame: Up to 14 weeks after dosing]

Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores [Time Frame: Up to 12 weeks after dosing]

Profiles of pharmacokinetics of plasma KHK6356 concentration [Time Frame: 2, 4, 8 and 12 weeks after dosing]

Change from baseline in the MDS-UPDRS subitem and total scores [Time Frame: Up to 12 weeks after dosing]

Patient global impression-improvement(PGI-I) score [Time Frame: Week 12]

Secondary ID(s)

6356-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors