OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
Overview
- Phase
- Phase 3
- Intervention
- onabotulinumtoxinA
- Conditions
- Muscle Spasticity
- Sponsor
- Allergan
- Enrollment
- 53
- Primary Endpoint
- Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago
Exclusion Criteria
- •Spasticity in the non-study upper limb that requires treatment
- •Presence of fixed contractures in of the study muscles in elbow or shoulder
- •Profound atrophy of muscles to be injected
- •Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
- •Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
- •Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
- •Condition other than stroke contributing to upper limb spasticity
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis
Arms & Interventions
onabotulinumtoxinA 500U
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
Intervention: onabotulinumtoxinA
onabotulinumtoxinA 300U
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
Intervention: onabotulinumtoxinA
placebo (normal saline)
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
Intervention: placebo (normal saline)
Outcomes
Primary Outcomes
Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
Time Frame: Baseline, Week 6
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Secondary Outcomes
- Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale(Baseline, Week 6)
- Change From Baseline in Pain on an 11-Point Scale(Baseline, Week 6)
- Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)(Baseline, Week 6)
- Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)(Baseline, Week 6)
- Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)(Baseline, Week 6)