Myobloc Atrophy Study

NCT02052024 | Completed Phase 4

• 1 other identifier: USWM-206-1010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Spasticity; Modified Ashworth Scale; MYOBLOC; Botox; Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Modified Ashworth Scale

  36 Weeks

Study Arms (2)

Botox

ACTIVE COMPARATOR

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

Drug: Botox

MYOBLOC

ACTIVE COMPARATOR

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

Drug: MYOBLOC

Interventions

Botox DRUG

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

Also known as: Botulinum Toxin Type A

Botox

MYOBLOC DRUG

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

Also known as: Botulinum Toxin Type B

MYOBLOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Georgetown University: lead
• Solstice Neurosciences: collaborator

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Spinal Cord Injuries; Brain Injuries; Neoplasms; Stroke; Muscle Spasticity; Muscular Atrophy

Interventions

Botulinum Toxins, Type A; rimabotulinumtoxinB

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Diseases; Craniocerebral Trauma; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Fernando Pagan, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

US (1)