Completed

Thioctic Acid Treatment for Mitochondrial Myopathy

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What is being tested

thioctic acid

Drug
Who is being recruted

Metabolic Diseases+12

+ Muscular Diseases

+ Musculoskeletal Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 1995
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00004770
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

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

1 patient to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Metabolic DiseasesMuscular DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesMitochondrial DiseasesGenetic Diseases, InbornMetabolism, Inborn ErrorsMitochondrial MyopathiesRare Diseases

Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers