Overview

Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy

Status:
Completed
Trial end date:
2000-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ohio State University
Treatments:
Albuterol
Criteria
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