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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Istradefylline

Criteria

Inclusion Criteria:

1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.

2. PD stages 1-3 for Modified Hoehn and Yahr Scale.

3. Be at least 30 years of age.

Exclusion Criteria:

1. Neurosurgical treatment for PD.

2. History of psychosis.

3. Diagnosis of cancer within 5 years.

4. Diagnosis of clinically significant illness of any organ system.

5. Mini-mental status examination score of 25 or less.

6. Taking any excluded medications.

7. History of drug or alcohol abuse or dependence within the past two years.

8. History of seizures or neurological malignant syndrome.

9. Clinical depression.

10. Pregnant or lactating females.