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Myobloc Atrophy Study

NCT02052024 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-12-16

No results posted yet for this study

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

Interventions

DRUG

Botox

Treatment group will receive 100 units of BOTOX and subjects 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.

Sponsors & Collaborators

  • Solstice Neurosciences

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Fernando Pagan, MD · MedStar Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02052024 on ClinicalTrials.gov