JPRN-jRCTs051180185已完成未知
Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - APISJ Study
Takahashi Makio0 个研究点目标入组 31 人开始时间: 2019年3月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 31
研究概览
简要总结
This is the first clinical study to investigate the efficacy of istradefylline, an adenosine A2A receptor antagonist, also known as a non-dopaminergic anti-parkinsonian agent, for the treatment of postural abnormality in patients with PD using UDRS as the primary outcome during the 24-week treatment. In the present study, Istradefylline was found to be effective for postural abnormalities in PD. Istradefylline may be a potential treatment option for postural abnormality in PD patients on levodopa treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 30age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) patients with wearing-off phenomena in parkinson's disease currently treated with levodopa-containing products
- •2) abnormal posture due to parkinson's disease within 2 years from onset of abnormal posture
- •3) at a stage of <= IV according to the modified hoehn and yahr scale (on state)
- •4) aged 30 years or older at the time of consent
- •5) patients who have given written consent. if the patient has difficulty in writing due to his or her condition, a representative may sign the written consent, subject to the patient's prior oral consent.
排除标准
- •1) a score of <= 20 on the mini-mental state examination (MMSE)
- •2) patients with abnormal posture which is not derived from parkinson's disease (e.g. compressed fracture of backbone, fracture of the pelvis, drug-induced abnormal posture)
- •3) patients with impact for evaluation by such treatment as deep brain stimulation transcranial magnetic stimulation or electroconvulsive therapy et cetera.
- •4) current use or plan to administer levodopa/carbidopa intestinal gel
- •5) ongoing treatment with botulinus toxin or passed treatment with botulinus toxin within 6 months
- •6) ongoing treatment with istradefylline or passed treatment with istradefylline within 1 year
- •7) moderate to severe hepatic disorder or current treatment with a strong inhibitor of cyp3a4
- •8) lactating, pregnant, or possibly pregnant women
- •9) other conditions judged by the investigator or subinvestigator to be unsuitable for participation in the research
研究者
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