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

This study has been completed.

First Received: December 5, 2001 Last Updated: January 31, 2006 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00027391

Purpose

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.

Condition	Intervention
Muscular Dystrophies	Drug: Albuterol Drug: Oxandrolone

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:	Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy

Resource links provided by NLM:

MedlinePlus related topics: Muscular Dystrophy

Drug Information available for: Oxandrolone Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	160
Study Start Date:	September 2001
Estimated Study Completion Date:	August 2004

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027391

Locations

United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

FDA Office of Orphan Products Development

Investigators

Principal Investigator:

John T. Kissel, M.D.

Ohio State University

More Information

No publications provided

Study ID Numbers:	FD-R-2029-01, FD-R-002029-01
Study First Received:	December 5, 2001
Last Updated:	January 31, 2006
ClinicalTrials.gov Identifier:	NCT00027391 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Muscle Weakness, Muscular Dystrophy

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Albuterol
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Oxandrolone
Neuromuscular Diseases
Musculoskeletal Diseases
Muscular Disorders, Atrophic

Tocolytic Agents
Therapeutic Uses
Adrenergic beta-Agonists
Nervous System Diseases
Anti-Asthmatic Agents
Pharmacologic Actions
Muscular Dystrophies
Anabolic Agents
Muscular Diseases
Genetic Diseases, Inborn
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Androgens

ClinicalTrials.gov processed this record on November 27, 2009