Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

Kyowa Kirin Co., Ltd.308 enrolled

Overview

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

308

Conditions

Parkinson's Disease

Interventions

IstradefyllineDRUG

Oral istradefylline (KW-6002) 20 or 40 mg once daily

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be willing and able to give written informed consent 2. Completion of the study 6002-009 Exclusion Criteria: 1. Mini-mental status examination score of 23 or less 2. Less than 70% of compliance in the study 6002-009 3. Emergency deviation in the study 6002-009 4. Pregnant females

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Adverse events

Secondary Outcomes

Reducing the mean total hours of awake time per day spent in the OFF state

Reducing the mean percentage of awake time per day spent in the OFF state

Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)

Change in Unified Parkinson's Disease Rating Scale (UPDRS)

Change in the Clinical Global Impression - Improvement scale (CGI-I)

Data from ClinicalTrials.gov

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