OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Terminated

Phase 3 Results N/A

Trial Description

This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.

Conditions

Interventions

  • Placebo (normal saline) Drug
    Intervention Desc: Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
    ARM 1: Kind: Experimental
    Label: placebo (normal saline)
    Description: Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
  • OnabotulinumtoxinA Drug
    Intervention Desc: OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.
    ARM 1: Kind: Experimental
    Label: onabotulinumtoxinA Dose 1
    Description: OnabotulinumtoxinA Dose 1 injected into predefined muscles of the study limb on Day 1.
    ARM 2: Kind: Experimental
    Label: onabotulinumtoxinA Dose 2
    Description: OnabotulinumtoxinA Dose 2 injected into predefined muscles of the study limb on Day 1.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale Baseline, Week 6 No
Secondary Change from Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale Baseline, Week 6 No
Secondary Clinical Global Impression (CGI) Of Overall Change by Physician Compared to Baseline Using a 9-Point Scale Baseline, Week 6 No
Secondary Change from Baseline in Pain on an 11-Point Scale Baseline, Week 6 No
Secondary Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score Baseline, Week 6 No

Sponsors