Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
NCT Number: NCT02052024
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Washington D.C., District of Columbia, 20007, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.
Other names: Botulinum Toxin Type A
Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.
Other names: Botulinum Toxin Type B
Time frame: 36 Weeks
The present pilot study is designed to assess the extent to which BTX-A (BOTOX) and BTX-B (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. Patient will complete a MRI of the tested muscle at baseline and at the end of the study. The MRI will be completed and read by the same radiologist throughout the study to account for inter rater variability. Note: The radiologist will be blinded to study treatment.
Time frame: 36 Weeks
The secondary endpoint is improvement in spasticity using the Modified Ashworth Scale. We will review all measures with our statistician. Modified Ashworth scoring will be completed at every visit to evaluate the extent of spasticity before, during and after treatment of which will be conducted by the same rater throughout course of the study.
Georgetown University
Other
Acronym: MAS
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