Myobloc Atrophy Study "MAS"

Completed

Phase 4 Results N/A

Trial Description

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

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

Interventions

  • Botox Drug
    Intervention Desc: Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.
    ARM 1: Kind: Experimental
    Label: Botox
    Description: Treatment group will receive 100 units of BOTOX and will receive 1-3 injections per muscle at each visit.
  • MYOBLOC Drug
    Other Names: rimabotulinumtoxinB, botulinum toxin type B
    Intervention Desc: Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.
    ARM 1: Kind: Experimental
    Label: MYOBLOC
    Description: Treatment group will receive 5,000 units of MYOBLOC and will receive 1-3 injections per muscle at each visit.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Volume and Cross-Sectional Area of Muscle 36 Weeks No
Secondary Modified Ashworth Scale 36 Weeks No

Sponsors