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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 April 2015
Main ID:	NCT00004685
Date of registration:	24/02/2000
Prospective Registration:	No
Primary sponsor:	Ohio State University
Public title:	Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy
Scientific title:
Date of first enrolment:	January 1998
Target sample size:	90
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00004685
Study type:	Interventional
Study design:	Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment

Contacts

Name:	John T. Kissel
Address:
Telephone:
Email:
Affiliation:	Ohio State University

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Muscular Dystrophy, Facioscapulohumeral

Intervention(s)

Drug: albuterol

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

199/13285

OSURF-FDR001293

OSURF-96H0022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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