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

NCT ID: NCT00199355

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-03-31

Brief Summary

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Detailed Description

To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Istradefylline (KW-6002)

Intervention Type: DRUG

Eligibility 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/DCI for at least one year, stable dose in past 4 weeks.

4. Currently take at least three doses of levodopa/DCI 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 120 minutes of OFF time on two 24 hour diaries.

8. On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.

9. Be at least 30 years of age.

Exclusion Criteria

1. Neurosurgical treatment for PD.

2. History of psychosis.

3. Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.

4. Diagnosis of cancer within 5 years.

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

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

7. Taking any excluded medications.

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

9. History of seizures or neurological malignant syndrome.

10. Clinical depression.

11. Pregnant or lactating females.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Locations

Tokyo, , Japan

Countries

Japan

Other Identifiers

6002-0406

Identifier Type: -

Identifier Source: org_study_id