Phase 3 Study of KW-6500 (Safety Study for Long-Term Self-Injection at Home in Patients with Parkinson's Disease)

Kyowa Hakko Kirin Co., Ltd.0 个研究点开始时间: 2009年8月18日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

发起方

Kyowa Hakko Kirin Co., Ltd.