Extended Long-Term Safety Study of KW-6500

Kyowa Kirin Co., Ltd.27 enrolled

Overview

This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

KW-6500DRUG

Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have given written informed consent * Patients who have completed the 6500-004 study

Locations (1)

Unnamed facility

Tōon, Ehime, Japan

Outcomes

Primary Outcomes

Adverse events and related adverse events

Time frame: From first administration of study drug through Study Week 52

Secondary Outcomes

Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS part III, response ratio, and UPDRS part II score

Time frame: From first administration of study drug through Study Week 52

Data from ClinicalTrials.gov

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