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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Kirin Pharmaceutical Development, Inc.; Kyowa Kirin, Inc.
• Treatments: Istradefylline; Levodopa

Criteria

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.