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

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Muscular Dystrophies

Intervention: Albuterol (Drug); Oxandrolone (Drug)

Phase: N/A

Status: Completed

Sponsored by: FDA Office of Orphan Products Development

Official(s) and/or principal investigator(s):
John T. Kissel, M.D., Principal Investigator, Affiliation: Ohio State University


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.

Clinical Details

Official title: Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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


- Pregnancy

- Known hypersensitivity to anabolic steroids

- Any medical or psychological condition that would interfere with the study

- Requirement for a wheelchair

Locations and Contacts

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

Starting date: September 2001
Last updated: March 24, 2015

Page last updated: August 23, 2015

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