Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy

National Center for Research Resources (NCRR)0 个研究点目标入组 34 人开始时间: 1996年8月1日最近更新: 2005年6月24日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 34

研究概览研究设计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

OBJECTIVES:

I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating polyneuropathy.

详细描述

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days. After a washout of at least 5 days, patients cross to the alternate therapy for 4 days.

研究设计

研究类型: Interventional
分配方式: Randomized
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 20 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•PROTOCOL ENTRY CRITERIA:
•-Disease Characteristics-- Clinical diagnosis of demyelinating neuropathy, i.e.: Hereditary motor and sensory neuropathy type I Chronic inflammatory demyelinating polyneuropathy meeting American Academy of Neurology AIDS Task Force criteria Multifocal motor neuropathy and conduction block Clinically stable for at least 6 months prior to entry --Prior/Concurrent Therapy-- At least 6 months since change in immunosuppressive dose --Patient Characteristics-- Age: 20 to 80 Hepatic: No predisposition to hepatic disease Renal: No predisposition to renal disease Cardiovascular: No predisposition to cardiac disease Other: No other medical condition affecting neuropathy or study evaluation No predisposition to seizures

排除标准

未提供

研究者

发起方

National Center for Research Resources (NCRR)

申办方类型

Nih

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