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	Treatment or Intervention
Muscular Dystrophies	Drug: Albuterol  Drug: Oxandrolone

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.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

John T. Kissel, M.D.,  Principal Investigator,  Ohio State University   

Study ID Numbers:  FD-R-2029-01; FD-R-002029-01
Record last reviewed:  November 2001
Record first received:  December 5, 2001
ClinicalTrials.gov Identifier:  NCT00027391
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09