Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500

Study Overview
=================
Brief Summary
-----------------
This is a placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections.

Official Title
-----------------
Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: KW-6500
* Drug: KW-6500 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Unified Parkinson's Disease Rating Scale (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 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
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The raw score change in UPDRS part III score |  | At the double blind period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent score change in UPDRS part III score and response ratio |  | At the double blind period |