Extended Long-Term Safety Study of KW-6500

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tōon, Ehime, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who have given written informed consent
Patients who have completed the 6500-004 study

Treatment and study plan

KW-6500

Drug

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

Other names: Apomorphine hydroshloride (USAN)

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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)

Acronym: 6500-005

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Feb 5, 2010
Registry last updated: Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed