Back to resultsAn Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Phase 3
Locations
United States
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: Completion of study 6002-INT-001 Not of childbearing potential Exclusion Criteria: Cancer within 5 years of enrollment ALT/AST levels > 2.5 times ULN
Sites / Locations
- Kyowa Pharmaceutical Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
Outcomes
Primary Outcome Measures
Safety as Measured by Adverse Events
Investigation of the long-term tolerability and safety of istradefylline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00199381
Brief Title
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
Official Title
An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Additional long-term safety data no longer needed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyowa Kirin, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.
Detailed Description
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.
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
Non-Randomized
Enrollment
504 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
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
Safety as Measured by Adverse Events
Description
Investigation of the long-term tolerability and safety of istradefylline
Time Frame
Every 2 months up to 32 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of study 6002-INT-001
Not of childbearing potential
Exclusion Criteria:
Cancer within 5 years of enrollment
ALT/AST levels > 2.5 times ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Sussman, MD
Organizational Affiliation
Kyowa Kirin, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kyowa Pharmaceutical Inc.
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
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