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

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

Conditions
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Muscle Spasticity, Stroke

Intervention / Treatment
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* Biological: onabotulinumtoxinA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For patients entering from the 191622-127 study, successful completion of study 191622-127 For patients entering directly into study 191622-129, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: onabotulinumtoxinA Dose 1<br>Up to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria. | Biological: onabotulinumtoxinA<br>* Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.<br>* Other names: botulinum toxin type A;|
| Experimental: onabotulinumtoxinA Dose 2<br>Up to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria. | Biological: onabotulinumtoxinA<br>* Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.<br>* Other names: botulinum toxin type A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale |  | Baseline, Up to 60 Weeks | 
| Change from Baseline in Pain on an 11-Point Scale |  | Baseline, Up to 60 Weeks | 
| Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score |  | Baseline, Up to 60 Weeks |