Overview

A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
0
Participant gender:
All
Summary
To establish the efficacy of 10, 20 and 40 mg/d 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.