Back to resultsA Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Istradefylline (KW-6002)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring levodopa, end of dose wearing off, OFF time
Eligibility Criteria
Inclusion Criteria: UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks. Currently take at least three doses of levodopa/carbidopa per day. Predictable end of dose wearing off. Able to satisfactorily complete Hauser version of a Parkinson's diary. Have an average of 180 minutes of OFF time on two 24 hour diaries. Be at least 30 years of age. Exclusion Criteria: Neurosurgical treatment for PD. History of psychosis. Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes. Diagnosis of cancer within 5 years. Mini-mental status examination score of 25 or less. History of seizures or neurologic malignant_syndrome.
Sites / Locations
- Kyowa Pharmaceutical Inc.
- Kyowa Pharmaceutical
Outcomes
Primary Outcome Measures
To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
Secondary Outcome Measures
To evaluate the dose-response of 10, 20 and 40 mg/d istradefylline using the primary efficacy outcome variable.
To evaluate the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the total hours of OFF time.
To evaluate the change in total hours of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).
To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
To evaluate the Patient Global Impression - Improvement scale (PGI-I).
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
To evaluate the safety of 10, 20, and 40 mg/d istradefylline by changes in safety parameters as noted in Section 7.2.4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00199420
Brief Title
A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa
Official Title
A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) 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
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyowa Kirin, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.
Detailed Description
To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
levodopa, end of dose wearing off, OFF time
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
580 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Istradefylline (KW-6002)
Primary Outcome Measure Information:
Title
To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.
Secondary Outcome Measure Information:
Title
To evaluate the dose-response of 10, 20 and 40 mg/d istradefylline using the primary efficacy outcome variable.
Title
To evaluate the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the total hours of OFF time.
Title
To evaluate the change in total hours of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).
Title
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).
Title
To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).
Title
To evaluate the Patient Global Impression - Improvement scale (PGI-I).
Title
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
Title
To evaluate the safety of 10, 20, and 40 mg/d istradefylline by changes in safety parameters as noted in Section 7.2.4.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
Currently take at least three doses of levodopa/carbidopa per day.
Predictable end of dose wearing off.
Able to satisfactorily complete Hauser version of a Parkinson's diary.
Have an average of 180 minutes of OFF time on two 24 hour diaries.
Be at least 30 years of age.
Exclusion Criteria:
Neurosurgical treatment for PD.
History of psychosis.
Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
Diagnosis of cancer within 5 years.
Mini-mental status examination score of 25 or less.
History of seizures or neurologic malignant_syndrome.
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
Facility Name
Kyowa Pharmaceutical
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa
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