Status:
COMPLETED
Study of KW-6002 (Istradefylline) 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:
PHASE3
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...
Eligibility Criteria
Inclusion
- Be willing and able to give written informed consent
- 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 \>=300 mg of levodopa/dopa-decarboxylase inhibitor 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
- On a stable dose of domperidone for at least 14 days before randomization
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 23 or less
- History of drug or alcohol abuse or dependence within the past two years
- History of psychosis
- History of significant drug allergies
- Taking anticonvulsants for seizures
- History of neuroleptic malignant syndrome
- Pregnant or lactating females
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00955526
Start Date
July 1 2009
End Date
February 1 2011
Last Update
August 29 2012
Active Locations (1)
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1
Tokyo, Japan