Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)

This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.

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Key information

Conditions

Muscular Dystrophies Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Muscle Weakness Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable side effects occur. Patients will undergo testing of muscle function. All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Presence of 4q35 "small fragment" of less than 40 kb by standard DNA testing
Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris
Weakness of scapular stabilizers or foot dorsiflexors
Ambulatory
Weakness grade 2 or worse in the arm using upper extremity grading scale

Exclusion criteria

Prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months
Concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers
Pregnancy
Known hypersensitivity to anabolic steroids
Any medical or psychological condition that would interfere with the study
Requirement for a wheelchair

Treatment and study plan

albuterol

Drug

Oxandrolone

Drug

Sponsors and collaborators

Lead sponsor

FDA Office of Orphan Products Development

Fed

Registry information

Official study title

Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy

Important dates

Study start: 2001
Study completion: 2004
First posted: Dec 7, 2001
Registry last updated: Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed