A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.

6002-US-013

To establish the efficacy of a 20 mg/day dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

2004-06-01

2005-11-01

2006-01-01

Completed

Early phase I

230

Inclusion Criteria: 1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD. 2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale. 3. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks. 4. Currently take at least three doses of levodopa/carbidopa per day. 5. Predictable end of dose wearing off. 6. Able to satisfactorily complete Hauser version of a Parkinson's diary. 7. Have an average of 180 minutes of OFF time on two 24 hour diaries. 8. Be at least 30 years of age. Exclusion Criteria: 1. Neurosurgical treatment for PD. 2. History of psychosis. 3. Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes. 4. Diagnosis of cancer within 5 years. 5. Mini-mental status examination score of 25 or less. 6. History of seizures or neurologic malignant_syndrome. 7. Clinical depression.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 230}}

2024-04-25