Back to results12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KW-6002 (istradefylline)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Levodopa therapy, End of dose wearing off, Off time
Eligibility Criteria
Inclusion Criteria:
- United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
- Modified Hoehn and Yahr Scale II-IV in the OFF state.
- Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
- Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
- Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
- Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization.
- At least 30 years of age and able to give written informed consent.
Exclusion Criteria:
- Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
- Treatment with MAO inhibitors except selegiline.
- Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
- Neurosurgical surgery for Parkinson's disease.
- Atypical parkinsonism or secondary parkinsonism variants.
- Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
- Mini-Mental Status Examination score of 25 or less.
- History of drug or alcohol abuse or dependence within 2 years.
- History of psychotic illness or seizures.
- Current clinically relevant depression disorder.
- History of neuroleptic malignant syndrome.
- Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.
Sites / Locations
- Contact Kyowa Pharmacuetical Inc.
Outcomes
Primary Outcome Measures
To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.
Secondary Outcome Measures
To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00456586
Brief Title
12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa
Official Title
A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day 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
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyowa Kirin, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
Detailed Description
A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
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 therapy, End of dose wearing off, Off time
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
KW-6002 (istradefylline)
Primary Outcome Measure Information:
Title
To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.
Secondary Outcome Measure Information:
Title
To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
Modified Hoehn and Yahr Scale II-IV in the OFF state.
Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization.
At least 30 years of age and able to give written informed consent.
Exclusion Criteria:
Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
Treatment with MAO inhibitors except selegiline.
Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
Neurosurgical surgery for Parkinson's disease.
Atypical parkinsonism or secondary parkinsonism variants.
Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
Mini-Mental Status Examination score of 25 or less.
History of drug or alcohol abuse or dependence within 2 years.
History of psychotic illness or seizures.
Current clinically relevant depression disorder.
History of neuroleptic malignant syndrome.
Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.
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
Contact Kyowa Pharmacuetical Inc.
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa
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