LOSIGAMONE AS MONOTHERAPY FOR COMPLEX PARTIAL SEIZURES

洛西加蒙作为复杂部分性癫痫发作的单一疗法

• 批准号: 2637096
• 负责人: RAJESH C SACHDEO
• 金额: $ 2.99万
• 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/2637096
• 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.

本合同是根据《合同法》授予的主协议订单（MAO）。 临床试验主协议的一般条款和条件 研究性抗癫痫药物的评价。独立而不 作为政府的代理人，承包商应提供所有必要的 服务、合格人员、材料、设备和设施，而不是 政府另有规定的，并应参加表演 多中心临床试验，以获得有关疗效的信息 和安全性，并获得 关于总药物和两种药物的药代动力学的信息 对映体。具体而言，该项目的主要目的是 根据ADD的目的获取信息 计划，以促进发展更有效和更少的毒性 抗癫痫药承包商应：（1）在以下期间获得IRB批准： I期阶段;（2）招募目标估计值为十二（12）例患者 在NINDS批准第二阶段性能后的12个月内。 假设75%的入组患者将接受随机化，每个中心 应计划入组至少12例患者，以提供9例患者， 完成审判。NIH政策要求临床研究包括 以这种方式，结果适用于一般 人口在接纳少数群体方面也有类似的政策; 和（3）与NINDS癫痫分支、药物申办者和 其他试验参与者同意统一的方案解释， 进行试验，并编写一份全面的最终报告， 作为科学出版物。