A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

Phase 2CompletedNCT00199433

Kyowa Kirin, Inc.160 enrolled

Overview

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease. This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Parkinson's Disease Movement Disorder Syndrome

Interventions

Istradefylline (KW-6002)DRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Early PD by UKPDS criteria 2. Mild to moderate difficulty daily activities 3. Females: Either postmenopausal or willing to use adequate contraception Exclusion Criteria: 1. Unable to discontinue current PD medication 2. Exposure to Levodopa for more than 1 month 3. Symptoms that may suggest a diagnosis other than Parkinson's disease 4. Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests

Locations (1)

Kyowa Pharmaceutical Inc.

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline in the UPDRS subscale III at endpoint.

Secondary Outcomes

Interim actual and change from baseline values in UPDRS total and subscale scores, Clinical Global Impression, measures of motor performance, and neuropsychological testing.

Safety:

Exam

vitals

weight

ECG

laboratory tests and adverse events

Data from ClinicalTrials.gov

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