Back to resultsA Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
istradefylline
Sponsored by
About this trial
This is an interventional trial for Parkinson's Disease focused on measuring long-term tolerability and safety, istradefylline treatment, levodopa/carbidopa
Eligibility Criteria
Inclusion Criteria:
Eligible subjects were:
- male or female
- at least 30 years of age
- had completed participation in a prior double-blind istradefylline trial
- met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
- had been treated with levodopa for at least 1 year
- had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline
- were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)
- had predictable end-of-dose wearing-off
Exclusion Criteria:
- none
Sites / Locations
- 48 Centers in the US and 4 in Canada
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
istradefylline
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00955045
Brief Title
A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Official Title
A Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyowa Kirin, Inc.
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study was to establish the long-term tolerability and safety of istradefylline treatment in subjects with Parkinson's disease treated with levodopa/carbidopa. In addition, treatment response and maintenance of response were assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
long-term tolerability and safety, istradefylline treatment, levodopa/carbidopa
7. Study Design
Study Phase
Phase 2, Phase 3
8. Arms, Groups, and Interventions
Arm Title
istradefylline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
istradefylline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible subjects were:
male or female
at least 30 years of age
had completed participation in a prior double-blind istradefylline trial
met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state
had been treated with levodopa for at least 1 year
had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline
were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation)
had predictable end-of-dose wearing-off
Exclusion Criteria:
none
Facility Information:
Facility Name
48 Centers in the US and 4 in Canada
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
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