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

Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 20 人开始时间: 2010年1月27日最近更新: 2023年10月17日

适应症

试验速览

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•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

•- 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.