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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00027391
Recruitment Status : Completed
First Posted : December 7, 2001
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

Tracking Information
First Submitted Date  ICMJE December 5, 2001
First Posted Date  ICMJE December 7, 2001
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE September 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Official Title  ICMJE Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Muscular Dystrophies
Intervention  ICMJE
  • Drug: Albuterol
  • Drug: Oxandrolone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
160
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00027391
Other Study ID Numbers  ICMJE FD-R-2029-01
FD-R-002029-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE FDA Office of Orphan Products Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John T. Kissel, M.D. Ohio State University
PRS Account FDA Office of Orphan Products Development
Verification Date November 2001

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