Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Withdrawn

Phase 3 Results N/A

Trial Description

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

Trial Stopped: The study was withdrawn prior to enrollment due to corporate decision.

Conditions

Interventions

  • OnabotulinumtoxinA Drug
    Intervention Desc: Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
    ARM 1: Kind: Experimental
    Label: onabotulinumtoxinA Dose 1
    Description: Up to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria.
    ARM 2: Kind: Experimental
    Label: onabotulinumtoxinA Dose 2
    Description: Up to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria.

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 Treated Muscle Groups Using a 6-Point Scale Baseline, Up to 60 Weeks No
Secondary Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale Baseline, Up to 60 Weeks No
Secondary Change from Baseline in Pain on an 11-Point Scale Baseline, Up to 60 Weeks No
Secondary Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score Baseline, Up to 60 Weeks No

Sponsors