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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Treatments: Albuterol; Oxandrolone

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