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

Completed · Not applicable

Conditions studied: Muscular Dystrophies

In brief

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.

Key facts

Study ID

NCT00027391

Run by

FDA Office of Orphan Products Development

People needed

160

Starts

2001-09-01

Expected to finish

2004-08-01

Last updated by the study team

2015-03-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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