ong-Term Safety Study of KW-6500
- Conditions
- Parkinson's Disease
- Registration Number
- JPRN-jRCT2080220819
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: adverse events<br>Efficacy: time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS partIII, response ratio, and UPDRS partII score
- Secondary Outcome Measures
Name Time Method