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.
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 partâ…¢ 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
