Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease

The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered as long-term subcutaneous self-injections in Parkinson's disease patients with motor response complications on levodopa therapy.

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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

Tokyo, 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 Parkinson's disease
Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state
Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale
Patients who have experienced a 30% or more improvement in UPDRS partⅢ score when tested for responsiveness to levodopa during the baseline period
Patients who have at least one OFF state per day
Patients who can understand the expression of OFF state, ON state, and dyskinesia
Patients or their families have a desire for self-injection of KW-6500

Exclusion criteria

Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)
Patients with orthostatic hypotension
Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite
Patients with a history of malignant syndrome
Patients with a diagnosis of cancer or evidence of continued disease
Patients who do not test negative in the direct Coombs' test
Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test, or women who cannot adhere to a reliable method of contraception
Patients who have received MAO inhibitors except selegiline
Patients with a history of mental disease (excluding psychiatric symptoms associated with Parkinson's disease)
Patients with a Mini-Mental State Examination (MMSE) score of 23 or less
Patients who are taking antipsychotics or central dopamine antagonists (excluding domperidone)
Patients who are receiving methyldopa or 5-HT3 receptor antagonists
Patients who are receiving reserpine or papaverine
Patients who have had a neurosurgical operation for Parkinson's disease
Patients who have had transcranial magnetic stimulation
Patients with a history of drug or alcohol abuse or dependence

Treatment and study plan

KW-6500

Drug

Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state

Other names: Apomorphine hydroshloride (USAN)

Primary outcomes

The incidence of adverse events after administration of KW-6500

Time frame: From first administration of study drug through Study Week 52
Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in Unified Parkinson's Disease Rating Scale (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 Long-Term Self-Administration at Home in Patients With Parkinson's Disease

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2012
First posted: Aug 10, 2009
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