LOSIGAMONE AS MONOTHERAPY IN THE TREATMENT OF COMPLEX

洛西加蒙作为治疗复杂性的单一疗法

• 批准号: 2879953
• 负责人: RAJESH C SACHDEO
• 金额: --
• 依托单位: UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 1999-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2879953
• 关键词: anticonvulsants; brain disorder chemotherapy; clinical research; clinical trial phase I; drug design /synthesis /production; drug screening /evaluation; human subject; human therapy evaluation; partial seizure; pharmacokinetics; stereoisomer

This contract represents a Master Agreement Order (MAO) award under the general terms and conditions of Master Agreement for the Clinical Evaluation Of Investigational Antiepileptic Drugs. Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, equipment and facilities, not otherwise provided by the Government, and shall participate in performance of a multi-center clinical trial to obtain information about the efficacy and safety of losigamone as a monotherapy regimen and to obtain information about the pharmacokinetics of the total drug and of the two enantiomers. Specifically, the principal purpose of this project is the acquisition of information in accordance with the purpose of the ADD Program to promote the development of more effective and less toxic antiepileptic drugs. The Contractor shall: (1) obtain IRB approval during the Phase l period; (2) enroll a target estimate of twelve (12) Patients within twelve months after the NINDS authorizes Phase II performance. Assuming 75% of the enrolled patients will be randomized, each center should plan to enroll at least 12 patients to provide 9 patients who complete the trial. NIH policy requires that clinical studies include both genders in such a manner that results are applicable to the general population. A similar policy exists regarding the inclusion of minorities; and (3) cooperate with the NINDS Epilepsy Branch, drug sponsor, and the other trial participants to agree on uniform protocol interpretation, conduct the trial, and develop a comprehensive final report suitable for submission as a scientific publication.

本合同代表主协议订单(MAO)授予 《临床总协议》的一般条款和条件 研究用抗癫痫药物的评价。独立和非独立 作为政府的代理人，承包商应提供所有必要的 服务、合格的人员、材料、设备和设施，不 政府另有规定的，应当参加演出 一项多中心临床试验，以获得有关疗效的信息 和安全性，作为一种单一的治疗方案，并获得 关于总药物和两种药物的药代动力学信息 对映体。具体地说，这个项目的主要目的是 根据ADD的目的获取信息 促进更有效和更少毒性的发展的计划 抗癫痫药。承包商应：(1)在以下期间获得内部审查委员会的批准 L期；(2)招募十二(12)名患者的目标估计 在NINDS批准第二阶段后的12个月内。 假设75%的登记患者将被随机分配，每个中心 应计划招募至少12名患者，为9名患者提供 完成试验。NIH的政策要求临床研究包括这两项 性别，以使结果适用于一般 人口。在纳入少数群体方面也有类似的政策； 以及(3)与NINDS癫痫分会、药物赞助商和 其他试验参与者就统一方案解释达成一致， 进行试验，并制定一份全面的最终报告， 以科学出版物的形式提交。