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

Phase 3

Withdrawn

• Conditions: Muscle Spasticity; Stroke
• Interventions: Biological: onabotulinumtoxinA

• 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

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Status Verified: 2014-08
• Study Start: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13
• Primary Completion: 2017-05
• Study Completion: 2017-05

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
onabotulinumtoxinA Dose 1	onabotulinumtoxinA	Up to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria.
onabotulinumtoxinA Dose 2	onabotulinumtoxinA	Up to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria.

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