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

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: KW-6500


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KW-6500<br> | Drug: KW-6500<br>* Subcutaneous injection of 1to 6 mg of KW-6500 for the OFF state<br>* Other names: Apomorphine hydroshloride (USAN);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events after administration of KW-6500 |  | 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 |  | From first administration of study drug through Study Week 52 |