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

Phase 2CompletedNCT00199355

Kyowa Kirin Co., Ltd.75 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease

Interventions

Istradefylline (KW-6002)DRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

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/DCI.

Secondary Outcomes

To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.

To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).

To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).

To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).

To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).

To evaluate the safety of 20 mg/d and 40mg/d doses of istradefylline.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.