Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy

National Center for Research Resources (NCRR)0 个研究点目标入组 1 人开始时间: 1995年10月1日最近更新: 2005年6月24日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 1

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 thioctic acid in treating a single patient with mitochondrial myopathy.

详细描述

PROTOCOL OUTLINE: The patient receives one thioctic acid tablet 3 times a day. If patient experiences no side effects after 1 week, 2 tablets are administered and given 3 times a day over 3 months for compassionate use.

The patient is followed at weeks 3, 8, and 12.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 0 Years 至 —（Child, Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•PROTOCOL ENTRY CRITERIA:
•-Disease Characteristics--
•Long standing ophthalmoparesis and fatiguable weakness of the limbs
•Mild ataxia and no central nervous system involvement
•History of mitochondrial DNA deletion and a measurable biochemical defect of the respiratory chain
•Steady deterioration in skeletal muscle mass and power over 5 years
•-Prior/Concurrent Therapy--
•Previous participation in studies of muscle disease natural history (CRC Protocol 183A)

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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