Text Size

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

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00027391
First received: December 5, 2001
Last updated: January 31, 2006
Last verified: November 2001
History of Changes

December 5, 2001
January 31, 2006
September 2001
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00027391 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Muscular Dystrophies
  • Drug: Albuterol
  • Drug: Oxandrolone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
August 2004
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027391
FD-R-2029-01, FD-R-002029-01
Not Provided
Not Provided
FDA Office of Orphan Products Development
Not Provided
Principal Investigator: John T. Kissel, M.D. Ohio State University
FDA Office of Orphan Products Development
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP