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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Muscle Spasticity Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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onabotulinumtoxinA Dose 1

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

Group Type EXPERIMENTAL

onabotulinumtoxinA

Intervention Type BIOLOGICAL

Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.

onabotulinumtoxinA Dose 2

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

Group Type EXPERIMENTAL

onabotulinumtoxinA

Intervention Type BIOLOGICAL

Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.

Interventions

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onabotulinumtoxinA

Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® botulinum toxin type A

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No