Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Muscular Dystrophies
Intervention: Albuterol (Drug); Oxandrolone (Drug)
Phase: N/A
Status: Completed
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s): John T. Kissel, M.D., Principal Investigator, Affiliation: Ohio State University
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.
Clinical Details
Official title: Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): 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
Locations and Contacts
Ohio State University Medical Center, Columbus, Ohio 43210, United States
Additional Information
Starting date: September 2001
Last updated: March 24, 2015
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