Status:
COMPLETED
A Phase 2b 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
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients wit...
Detailed Description
To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's diseas...
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/dopa-decarboxylase inhibitor for at least one year.
- Taking at least three doses and \>=300mg of levodopa per day for at least four weeks before randomization.
- Predictable end of dose wearing off.
- Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.
- Have an average of two hours of OFF time on 24-hour diaries.
- On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization.
- Be at least 20 years of age.
- Be willing and able to give written informed consent.
Exclusion
- Taking any excluded medications.
- Neurosurgical treatment or Transcranial Magnetic Stimulation for PD.
- Diagnosis of cancer within 5 years.
- Diagnosis of clinically significant illness of any organ system.
- Diagnosis of dementia or mini-mental status examination score of 25 or less.
- History of drug or alcohol abuse or dependence within the past two years.
- History of psychosis.
- Significant drug allergies.
- Taking anticonvulsants for seizures.
- History of neurological malignant syndrome.
- Pregnant or lactating females.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT00455507
Start Date
March 1 2007
End Date
August 1 2008
Last Update
August 29 2012
Active Locations (1)
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1
Tokyo, Japan