Thioctic Acid and Alpha-lipoic Acid and thioctic acid in Mitochondrial Myopathy - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Mitochondrial Myopathy

Intervention / Treatment

Drug: thioctic acid

Detailed Description

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.

Study Type

Interventional

Enrollment

1

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Rochester

Investigators

Study Chair: Robert Griggs, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1995

Study Registration Dates

First Submitted

February 24, 2000

First Submitted That Met QC Criteria