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Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy
This study is ongoing, but not recruiting participants.
Study NCT00004685   Information provided by FDA Office of Orphan Products Development
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes

February 24, 2000
June 23, 2005
January 1998
 
 
 
Complete list of historical versions of study NCT00004685 on ClinicalTrials.gov Archive Site
 
 
 
Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy
 

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.

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.

 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control
Muscular Dystrophy, Facioscapulohumeral
Drug: albuterol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
90
 
 

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Facioscapulohumeral dystrophy Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris Weakness of scapular stabilizers or foot dorsiflexors Weakness of grade 2 or worse in the arm using the upper extremity grading scale No other neuromuscular diseases that may mimic the clinical presentation of facioscapulohumeral dystrophy: Ptosis or ophthalmoparesis (other than congenital strabismus) Elbow contractures Strictly unilateral weakness Dermatomyositis-like skin rash Symmetric distal sensory loss Muscle biopsy findings of mitochondrial myopathy, chronic denervation, dermatomyositis, inclusion body myositis, or congenital myopathy Electromyographic (EMG) findings of myotonia, fasciculations, or neurogenic motor unit potentials --Prior/Concurrent Therapy-- Endocrine therapy: No prior long term use of oral corticosteroids for more than 1 year At least 3 months since prior use of corticosteroids No concurrent use of immunosuppressive agents Surgery: No concurrent surgeries Other: No concurrent use of sympathomimetic agents, antidepressants, or beta receptor blockers --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Cardiovascular: No cardiovascular disease, including hypertension and coronary artery disease Other: Not pregnant or nursing No concurrent uncontrolled medical or psychological condition

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004685
 
199/13285, OSURF-96H0022, OSURF-FDR001293
FDA Office of Orphan Products Development
Ohio State University
Study Chair: John T. Kissel Ohio State University
FDA Office of Orphan Products Development
March 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP