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

Primary Purpose

Muscular Dystrophies

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Albuterol
Oxandrolone
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophies focused on measuring Muscle Weakness, Muscular Dystrophy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 5, 2001
Last Updated
March 24, 2015
Sponsor
FDA Office of Orphan Products Development
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1. Study Identification

Unique Protocol Identification Number
NCT00027391
Brief Title
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Official Title
Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
FDA Office of Orphan Products Development

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies
Keywords
Muscle Weakness, Muscular Dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Albuterol
Intervention Type
Drug
Intervention Name(s)
Oxandrolone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T. Kissel, M.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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

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