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

Sponsor
FDA Office of Orphan Products Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00027391
Collaborator
(none)
160
Enrollment
1
Location
35
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
Study Start Date :
Sep 1, 2001
Study Completion Date :
Aug 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • FDA Office of Orphan Products Development

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00027391
    Other Study ID Numbers:
    • FD-R-2029-01
    • FD-R-002029-01
    First Posted:
    Dec 7, 2001
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Nov 1, 2001
    Keywords provided by , ,
    Muscle Weakness, Muscular Dystrophy
    Additional relevant MeSH terms:
    Muscular Dystrophies
    Albuterol
    Oxandrolone

    Study Results

    No Results Posted as of Mar 25, 2015