Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Launched by KYOWA KIRIN CO., LTD. · Aug 7, 2009

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Be willing and able to give written informed consent
• • 2. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
• • 3. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
• • 4. On levodopa/dopa-decarboxylase inhibitor for at least one year
• • 5. Taking at least three doses and \>=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
• • 6. Predictable end of dose wearing off
• • 7. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
• • 8. Have an average of two hours of OFF time on 24-hour diaries
• • 9. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
• • 10. On a stable dose of domperidone for at least 14 days before randomization
• Exclusion Criteria:
• • 1. Taking any excluded medications
• • 2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
• • 3. Diagnosis of cancer within 5 years
• • 4. Diagnosis of clinically significant illness of any organ system
• • 5. Diagnosis of dementia or mini-mental status examination score of 23 or less
• • 6. History of drug or alcohol abuse or dependence within the past two years
• • 7. History of psychosis
• • 8. History of significant drug allergies
• • 9. Taking anticonvulsants for seizures
• • 10. History of neuroleptic malignant syndrome
• • 11. Pregnant or lactating females