Study Stopped
Additional long-term safety data no longer needed
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
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.
1 other identifier
interventional
504
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 30, 2013
CompletedMay 17, 2024
April 1, 2024
3 years
September 12, 2005
April 4, 2013
April 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety as Measured by Adverse Events
Investigation of the long-term tolerability and safety of istradefylline
Every 2 months up to 32 months
Study Arms (1)
Single Arm
EXPERIMENTALTreatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
Interventions
Oral istradefylline (KW-6002) 20 or 40 mg once daily.
Eligibility Criteria
You may qualify if:
- Completion of study 6002-INT-001
- Not of childbearing potential
You may not qualify if:
- Cancer within 5 years of enrollment
- ALT/AST levels \> 2.5 times ULN
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyowa Kirin, Inc.lead
- Kyowa Kirin Co., Ltd.collaborator
Study Sites (1)
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, 08540, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The Sponsor decided to terminate the study early (not for safety reasons); as a result 323 subjects discontinued early. Mean duration of therapy was 18.7 months (0.4 to 31.4 months); median duration was 21.0 months. Total exposure 767 subject years.
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Kyowa Hakko Kirin Pharma, Inc.
Study Officials
- STUDY DIRECTOR
Neil Sussman, MD
Kyowa Kirin, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
October 1, 2005
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 17, 2024
Results First Posted
July 30, 2013
Record last verified: 2024-04