Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity | NCT02145689 | Trialant
WithdrawnInterventionalPhase 3Updated Aug 13, 2014
Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
ClinicalTrials.gov ID
NCT02145689
Lead Sponsor
AllerganINDUSTRY
Overall Status
Withdrawn
Study Type
Interventional
Phase
Phase 3
Enrollment
0Actual
Last Update Posted
Aug 13, 2014Estimated
Start Date
Aug 2014
Primary Completion Date
May 2017Estimated
Completion Date
May 2017Estimated
Brief Summary
This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
Muscle Spasticity
Stroke
onabotulinumtoxinA
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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