OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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This is a 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 500U

OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.

Group Type EXPERIMENTAL

onabotulinumtoxinA

Intervention Type BIOLOGICAL

OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.

onabotulinumtoxinA 300U

OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.

Group Type EXPERIMENTAL

onabotulinumtoxinA

Intervention Type BIOLOGICAL

OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.

placebo (normal saline)

Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

Group Type PLACEBO_COMPARATOR

placebo (normal saline)

Intervention Type DRUG

Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

Interventions

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onabotulinumtoxinA

OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.

Intervention Type BIOLOGICAL

placebo (normal saline)

Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

Intervention Type DRUG

Other Intervention Names

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BOTOX® botulinum toxin type A

Eligibility Criteria

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Inclusion Criteria

* 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