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Myobloc Atrophy Study

NCT ID: NCT02052024

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Spasticity Modified Ashworth Scale MYOBLOC Botox Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Botox

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

Group Type ACTIVE_COMPARATOR

Botox

Intervention Type DRUG

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 will receive 1-3 injections per muscle at each visit.

Group Type ACTIVE_COMPARATOR

MYOBLOC

Intervention Type DRUG

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

Interventions

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Botox

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

Intervention Type DRUG

MYOBLOC

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

Intervention Type DRUG

Other Intervention Names

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Botulinum Toxin Type A Botulinum Toxin Type B

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solstice Neurosciences

INDUSTRY

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando Pagan, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Georgetown University Hospital

Locations

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Medstar Georgetown University Hospital

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

Site Status

Countries

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United States

Other Identifiers

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USWM-206-1010

Identifier Type: -

Identifier Source: org_study_id