CompletedPhase 4

Myobloc Atrophy Study

United States10 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women aged 18 or older with spasticity secondary to either a disorder or trauma, such as a spinal cord injury (SCI), a brain injury, a tumor, a stroke, multiple sclerosis (MS), or a peripheral nerve injury. * Participants must have the ability to provide written consent to participate in the study. Exclusion Criteria: * Patients who have received BTX-A or BTX-B in the past in the skeletal muscle group under investigation or patients who have had an allergic response to BTX-A or BTX-B in the past. * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis. Females who are pregnant or breastfeeding. Subjects taking Aminoglycosides or other agents interfering with neuromuscular function.

What they're measuring

Volume and Cross-Sectional Area of Muscle

Timeframe: 36 Weeks

Trial details

NCT IDNCT02052024

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Spasticity Secondary to Either a Disorder or Trauma trials