Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
Phase 3
Withdrawn
- Conditions
- Muscle SpasticityStroke
- Registration Number
- NCT02145689
- Lead Sponsor
- Allergan
- Brief Summary
This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score Baseline, Up to 60 Weeks 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of onabotulinumtoxinA in managing poststroke upper limb spasticity?
How does onabotulinumtoxinA compare to baclofen in long-term efficacy for upper limb spasticity post-stroke?
What biomarkers correlate with response to onabotulinumtoxinA in chronic poststroke spasticity management?
What adverse events are associated with repeated onabotulinumtoxinA injections in stroke survivors with spasticity?
Are there combination therapies involving onabotulinumtoxinA that improve outcomes in upper limb spasticity post-stroke?