OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Allergan

Status and phase: Terminated; Phase 3

Conditions: Stroke; Muscle Spasticity

Treatments: Biological: onabotulinumtoxinA; Drug: placebo (normal saline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02145676

191622-127

2013-002346-37 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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53 participants in 3 patient groups, including a placebo group

onabotulinumtoxinA 500U

Experimental group

Description:

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

Treatment:

Biological: onabotulinumtoxinA

onabotulinumtoxinA 300U

Experimental group

Description:

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

Treatment:

Biological: onabotulinumtoxinA

placebo (normal saline)

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo (normal saline)