Back to resultsA Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
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, monotherapy
Eligibility Criteria
Inclusion Criteria: UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD. PD stages 1-3 for Modified Hoehn and Yahr Scale. Be at least 30 years of age. Exclusion Criteria: Neurosurgical treatment for PD. History of psychosis. 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 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).
Secondary Outcome Measures
To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score.
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 40mg/d doses of istradefylline.
Full Information
NCT ID
NCT00250393
First Posted
November 4, 2005
Last Updated
August 28, 2012
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00250393
Brief Title
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
Official Title
Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 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 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).
Detailed Description
To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: Condition A (doses of 40mg/d istradefylline) in Period 1 followed by Condition B (matching placebo) in Period 2 (putting 4 weeks interval phase between two periods ) or Condition B in Period 1 followed by Condition A in Period 2(putting 4 weeks interval phase between two periods ). Patients will be participated 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, monotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (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 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score.
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 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 1-3 for Modified Hoehn and Yahr Scale.
Be at least 30 years of age.
Exclusion Criteria:
Neurosurgical treatment for PD.
History of psychosis.
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
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