Clinical Trials Directory

Trials / Completed

CompletedNCT02052024

Myobloc Atrophy Study

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Georgetown University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGBotoxTreatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.
DRUGMYOBLOCTreatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.

Timeline

Start date
2014-05-01
Primary completion
2015-08-01
Completion
2015-08-01
First posted
2014-01-31
Last updated
2015-12-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02052024. Inclusion in this directory is not an endorsement.