Myobloc Atrophy Study

Phase 4

Completed

• Conditions: Spasticity Secondary to Either a Disorder or Trauma; Spinal Cord Injury (SCI); Stroke; Brain Injury; Tumor
• Interventions: Drug: MYOBLOC; Drug: Botox

• Registration Number: NCT02052024
• Lead Sponsor: Georgetown University

Brief 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.

Study Timeline

• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Study Start: 2014-05
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MYOBLOC	MYOBLOC	Treatment group will receive 5,000 units of MYOBLOC and will receive 1-3 injections per muscle at each visit.
Botox	Botox	Treatment group will receive 100 units of BOTOX and will receive 1-3 injections per muscle at each visit.

Primary Outcome Measures

Name	Time	Method
Volume and Cross-Sectional Area of Muscle	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.

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	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.

Trial Locations

Locations (1)

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States