BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity

Active, not recruiting

Phase 3 Results N/A

Trial Description

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric 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 into the upper limb muscles and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments. Treatment dosing will be according to investigator judgment not to exceed a maximum of 10 U per kg of body weight (10 U/kg) per treatment.
    ARM 1: Kind: Experimental
    Label: BOTOX®
    Description: Subjects will receive intramuscular injections of BOTOX® (botulinum toxin Type A) into the upper limb muscles and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments. Treatment dosing will be according to investigator judgment not to exceed a maximum of 10 U per kg of body weight (10 U/kg) per treatment.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of Patients Reporting at Least One Adverse Event 60 Weeks No

Sponsors