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The present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause muscle atrophy in spastic patients. The primary objective is to assess whether there is statistically significant difference in muscle atrophy between the two groups over a one year period.
Botulinum toxin has long been used as a clinical application for the treatment of overactive skeletal and smooth muscles, i.e. spasticity. The benefits of botulinum therapy are indisputable, however, muscle atrophy is one main adverse effect that may hinder a patient's strength and decrease the ability for the practitioner to accurately administer botulinum toxin to a specific muscle group. This, in turn may cause unintentional weakness of adjacent muscle groups through inaccurate targeting or diffusion of botulinum toxin. Currently, only two serotypes (abbreviated to BTX-A (BOTOX, XEOMIN and DYSPORT) and BTX-B (MYOBLOC), respectively) are used in clinical practice for spasticity. Research has shown that both BTX-A and BTX-B are efficacious in the treatment of spasticity. However, there is no documented literature evaluating if there is a statistically significant difference in the degree of muscle atrophy using BTX-A versus BTX-B.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Start Date
May 1, 2014
Primary Completion Date
August 1, 2015
Completion Date
August 1, 2015
Last Updated
December 16, 2015
10
ACTUAL participants
Botox
DRUG
MYOBLOC
DRUG
Lead Sponsor
Georgetown University
Collaborators
NCT04521881
NCT07455136
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06725108