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

Phase 3CompletedNCT00199420

Kyowa Kirin, Inc.580 enrolled

Overview

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.

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. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

580

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/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.

Locations (2)

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, United States

Kyowa Pharmaceutical

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

To establish the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/carbidopa.

Secondary Outcomes

To evaluate the dose-response of 10, 20 and 40 mg/d istradefylline using the primary efficacy outcome variable.

To evaluate the efficacy of 10, 20 and 40 mg/d istradefylline for reducing the total hours of OFF time.

To evaluate the change in total hours 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) Motor Examination score (part III) and/or in Activities of Daily Living (ADL) score (part II).

To evaluate the change in Parkinson's Disease Questionnaire (PDQ-39) and Medical Outcomes Study 36-item Short Form (SF-36).

To evaluate the Patient Global Impression - Improvement scale (PGI-I).

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

To evaluate the safety of 10, 20, and 40 mg/d istradefylline by changes in safety parameters as noted in Section 7.2.4.

Data from ClinicalTrials.gov

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