Myobloc Atrophy Study

Phase 4CompletedNCT02052024

Georgetown University10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

BotoxDRUG

Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.

MYOBLOCDRUG

Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Volume and Cross-Sectional Area of Muscle

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

Secondary Outcomes

Modified Ashworth Scale

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.

Time frame: 36 Weeks

Data from ClinicalTrials.gov

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