Parkinson's Disease
Conditions
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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) part III 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The raw score change in UPDRS part III score at the double blind period | — |
Secondary
| Measure | Time frame |
|---|---|
| The percent score change in UPDRS Part III score and response ratio at the double blind period | — |
Outcome results
None listed