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Myobloc Atrophy Study (MAS)

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ClinicalTrials.gov Identifier: NCT02052024
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : December 16, 2015
Sponsor:
Collaborator:
Solstice Neurosciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spasticity Secondary to Either a Disorder or Trauma Spinal Cord Injury (SCI) Brain Injury Tumor Stroke Drug: Botox Drug: MYOBLOC Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myobloc Atrophy Study
Study Start Date : May 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: Botox
Treatment group will receive 100 units of BOTOX and will receive 1-3 injections per muscle at each visit.
Drug: Botox
Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.
Other Name: Botulinum Toxin Type A

Active Comparator: MYOBLOC
Treatment group will receive 5,000 units of MYOBLOC and will receive 1-3 injections per muscle at each visit.
Drug: MYOBLOC
Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.
Other Name: Botulinum Toxin Type B




Primary Outcome Measures :
  1. Volume and Cross-Sectional Area of Muscle [ Time Frame: 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 :
  1. Modified Ashworth Scale [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052024


Locations
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United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Solstice Neurosciences
Investigators
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Principal Investigator: Fernando Pagan, MD MedStar Georgetown University Hospital

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02052024     History of Changes
Other Study ID Numbers: USWM-206-1010
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Keywords provided by Georgetown University:
Spasticity
Modified Ashworth Scale
MYOBLOC
Botox
Muscle Atrophy

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Spinal Cord Injuries
Atrophy
Muscle Spasticity
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
rimabotulinumtoxinB
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents