Back to resultsA Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
Japan
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 Parkinson's Disease, 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/DCI for at least one year, stable dose in past 4 weeks. Currently take at least three doses of levodopa/DCI per day. Predictable end of dose wearing off. Able to satisfactorily complete Hauser version of a Parkinson's diary. Have an average of 120 minutes of OFF time on two 24 hour diaries. On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization. Be at least 30 years of age. Exclusion Criteria: Neurosurgical treatment for PD. History of psychosis. Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant. Diagnosis of cancer within 5 years. Diagnosis of clinically significant illness of any organ system. Mini-mental status examination score of 25 or less. Taking any excluded medications. History of drug or alcohol abuse or dependence within the past two years. History of seizures or neurological malignant syndrome. Clinical depression. Pregnant or lactating females.
Sites / Locations
Outcomes
Primary Outcome Measures
To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.
Secondary Outcome Measures
To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.
To evaluate the change in percentage 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).
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00199355
Brief Title
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Official Title
Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To establish the efficacy of 20 mg/day and 40 mg/day doses 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 20 mg/d and 40mg/d doses 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 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
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 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (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 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.
Title
To evaluate the change in percentage 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).
Title
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
Title
To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
Title
To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.
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/DCI for at least one year, stable dose in past 4 weeks.
Currently take at least three doses of levodopa/DCI per day.
Predictable end of dose wearing off.
Able to satisfactorily complete Hauser version of a Parkinson's diary.
Have an average of 120 minutes of OFF time on two 24 hour diaries.
On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
Be at least 30 years of age.
Exclusion Criteria:
Neurosurgical treatment for PD.
History of psychosis.
Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
Diagnosis of cancer within 5 years.
Diagnosis of clinically significant illness of any organ system.
Mini-mental status examination score of 25 or less.
Taking any excluded medications.
History of drug or alcohol abuse or dependence within the past two years.
History of seizures or neurological malignant syndrome.
Clinical depression.
Pregnant or lactating females.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Kyowa Kirin Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
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