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

Tracking Information

First Received Date ^ICMJE

December 5, 2001

Last Updated Date

January 31, 2006

Start Date ^ICMJE

September 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00027391 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Condition ^ICMJE

Muscular Dystrophies

Intervention ^ICMJE

Drug: Albuterol
Drug: Oxandrolone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

August 2004

Primary Completion Date

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00027391

Responsible Party

Study ID Numbers ^ICMJE

FD-R-2029-01, FD-R-002029-01

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John T. Kissel, M.D.

Ohio State University

Information Provided By

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