Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients (6002-010)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Istradefylline
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa, end of dose wearing off, OFF time
Eligibility Criteria
Inclusion Criteria:
- Be willing and able to give written informed consent
- Completion of the study 6002-009
Exclusion Criteria:
- Mini-mental status examination score of 23 or less
- Less than 70% of compliance in the study 6002-009
- Emergency deviation in the study 6002-009
- Pregnant females
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Istradefylline
Arm Description
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Reducing the mean total hours of awake time per day spent in the OFF state
Reducing the mean percentage of awake time per day spent in the OFF state
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Change in the Clinical Global Impression - Improvement scale (CGI-I)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00957203
Brief Title
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients
Acronym
6002-010
Official Title
Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, levodopa, end of dose wearing off, OFF time
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Istradefylline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Istradefylline
Other Intervention Name(s)
KW-6002
Intervention Description
Oral istradefylline (KW-6002) 20 or 40 mg once daily
Primary Outcome Measure Information:
Title
Adverse events
Secondary Outcome Measure Information:
Title
Reducing the mean total hours of awake time per day spent in the OFF state
Title
Reducing the mean percentage of awake time per day spent in the OFF state
Title
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Title
Change in the Clinical Global Impression - Improvement scale (CGI-I)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be willing and able to give written informed consent
Completion of the study 6002-009
Exclusion Criteria:
Mini-mental status examination score of 23 or less
Less than 70% of compliance in the study 6002-009
Emergency deviation in the study 6002-009
Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Kyowa Kirin Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients
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