BOTOX® Treatment in Pediatric Upper Limb Spasticity

Completed

Phase 3 Results N/A

Trial Description

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.

Conditions

Interventions

  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: Subjects will receive intramuscular injections of botulinum toxin Type A 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
    ARM 1: Kind: Experimental
    Label: BOTOX® 3 U/kg
    Description: Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 3 U per kg of body weight (3 U/kg) into specified muscles of the upper limb.
    ARM 2: Kind: Experimental
    Label: BOTOX® 6 U/kg
    Description: Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb.
  • Normal Saline (Placebo) Drug
    Intervention Desc: Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Subjects will receive intramuscular injections of normal saline (placebo) into specified muscles of the upper limb.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group Using a 6-Point Scale Baseline, 6 Weeks No
Primary Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale Baseline, 6 Weeks No
Secondary Change from Baseline in MAS-B Score of the Finger Flexor Muscle Group Using a 6-Point Scale Baseline, 6 Weeks No
Secondary Goal Attainment Score as Assessed by Physician Using a 6-Point Scale Week 12 No
Secondary Change from Baseline in Severity of Spasticity of the Principal Muscle Group Calculated Using the Modified Tardieu Scale (MTS) Baseline, 6 Weeks No

Sponsors