A Study of KW-6356 in Subjects With Early Parkinson's Disease
March 19, 2018 updated by: Kyowa Kirin Co., Ltd.
An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
175
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kyoto, Japan
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Hokkaido
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Asahikawa City, Hokkaido, Japan
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Hyogo
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Akashi, Hyogo, Japan
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Kanagawa
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Fujisawa, Kanagawa, Japan
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Osaka
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Suita, Osaka, Japan
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Tokyo
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Nakano, Tokyo, Japan
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Setagaya, Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: KW-6356 Low Dose
Oral administration
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Oral administration
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Experimental: KW-6356 High Dose
Oral administration
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Oral administration
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Placebo Comparator: Placebo
Oral administration
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Oral administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
Time Frame: Up to 12 weeks after dosing
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Up to 12 weeks after dosing
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical global impression-improvement(CGI-I) score
Time Frame: Week 12
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Week 12
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Patient global impression-improvement(PGI-I) score
Time Frame: Week 12
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Week 12
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Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores
Time Frame: Up to 12 weeks after dosing
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Up to 12 weeks after dosing
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Number and percentage of subjects with treatment-emergent adverse events
Time Frame: Up to 14 weeks after dosing
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Up to 14 weeks after dosing
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Profiles of pharmacokinetics of plasma KHK6356 concentration
Time Frame: 2, 4, 8 and 12 weeks after dosing
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2, 4, 8 and 12 weeks after dosing
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Change from baseline in the MDS-UPDRS subitem and total scores
Time Frame: Up to 12 weeks after dosing
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Up to 12 weeks after dosing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
November 22, 2017
Study Completion (Actual)
December 8, 2017
Study Registration Dates
First Submitted
October 17, 2016
First Submitted That Met QC Criteria
October 18, 2016
First Posted (Estimate)
October 20, 2016
Study Record Updates
Last Update Posted (Actual)
March 20, 2018
Last Update Submitted That Met QC Criteria
March 19, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6356-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.