Status:
COMPLETED
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00199355
Start Date
April 1 2005
End Date
March 1 2006
Last Update
May 23 2014
Active Locations (1)
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1
Tokyo, Japan