Myobloc Atrophy Study

Stroke Clinical Trial

— MAS  

Official title:

Myobloc Atrophy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052024
• Other study ID #: USWM-206-1010
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2014
• Last updated: December 15, 2015
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Botox
Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.
• MYOBLOC
Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.

Locations

Country	Name	City	State
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Solstice Neurosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 Weeks	No
Secondary	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.	36 Weeks	No