Clinical Trial: Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

OBJECTIVES: I. Determine whether albuterol increases strength in patients with facioscapulohumeral dystrophy as measured by quantitative voluntary isometric contraction testing.

II. Determine whether albuterol increases muscle mass in this patient population as determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry (DEXA).

III. Examine the long term safety of albuterol in this patient population.

Detailed Summary:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized into one of three treatment groups. The first group receives placebo. The second group receives low dose albuterol orally every 12 hours. The third group receives high dose albuterol orally every 12 hours. Treatment continues for 52 weeks unless unacceptable side effects occur.

All patients return for follow up assessments at weeks 4, 12, 24, and 52.

Completion date provided represents the completion date of the grant per OOPD records

Sponsor: Ohio State University

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: February 24, 2000
Date Started: January 1998
Date Completion: September 2000
Last Updated: March 24, 2015
Last Verified: March 1999