临床试验/NCT00994916

NCT00994916No Longer Available不适用

Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

David Lacomis, MD0 个研究点开始时间: 2009年10月14日最近更新: 2019年7月9日

适应症

试验速览

阶段: 不适用
状态: No Longer Available
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).

详细描述

Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained.

The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board.

The investigator has a hold on enrolling new subjects.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of LEMS
•Over 18 years old
•Medically stable
•If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as "double-barrier contraception" during the study

排除标准

•Known sensitivity to 3,4 DAP
•History of past or current seizures
•History of severe asthma
•Believed by the investigator to be unable to comply with the protocol
•Unable to provide informed consent

研究者

发起方

David Lacomis, MD

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

David Lacomis, MD

Professor of Neurology and Pathology

University of Pittsburgh

相似试验

No Longer Available

不适用

Treatment of Lambert-Eaton Syndrome With 3,4 DAPLambert Eaton Myasthenic Syndrome

NCT00704925David P. Richman, MD

Approved For Marketing

不适用

Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton SyndromeLambert Eaton Myasthenic Syndrome

NCT01825395University of Colorado, Denver

No Longer Available

不适用

Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic SyndromeLambert-Eaton Myasthenic Syndrome

NCT01373333The Cleveland Clinic

终止

2 期

Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS)Muscle Weakness

NCT02090725Jeffrey A. Cohen, MD4

No Longer Available

不适用

3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenia (CM)Lambert-Eaton Myasthenic Syndrome (LEMS)Congenital Myasthenia (CM)

NCT02012933Oregon Health and Science University