OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Muscle Spasticity, Stroke

In brief

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

Key facts

Study ID

NCT02145676

Run by

Allergan

People needed

53

Starts

2014-05-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

You may not qualify if…

• 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

Where it is running

• Study site — Overland Park, Kansas, United States
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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