Expired Study
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Columbus, Ohio 43210


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00027391


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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