A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa.

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

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• 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/dopa-decarboxylase inhibitor for at least one year.

4. Taking at least three doses and >=300mg of levodopa per day for at least four weeks before randomization.

5. Predictable end of dose wearing off.

6. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.

7. Have an average of two hours of OFF time on 24-hour diaries.

8. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization.

9. Be at least 20 years of age.

10. Be willing and able to give written informed consent.

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 25 or less.

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

7. History of psychosis.

8. Significant drug allergies.

9. Taking anticonvulsants for seizures.

10. History of neurological malignant syndrome.

11. Pregnant or lactating females.