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

Muscular Dystrophies Clinical Trial

Official title:

Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027391
• Other study ID #: FD-R-2029-01
• Secondary ID: FD-R-002029-01
• Status: Completed
• Phase: N/A
• First received: December 5, 2001
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: August 2004

Study information

• Verified date: November 2001
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral

Intervention

Drug:
• Albuterol

• Oxandrolone

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development

Country where clinical trial is conducted

United States,