Myobloc Atrophy Study

Completed · Phase 4

Conditions studied: Spasticity Secondary to Either a Disorder or Trauma, Spinal Cord Injury (SCI), Brain Injury, Tumor, Stroke

In brief

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.

Key facts

Study ID

NCT02052024

Run by

Georgetown University

People needed

10

Starts

2014-05-01

Expected to finish

2015-08-01

Last updated by the study team

2015-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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