BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

Study Overview
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Brief Summary
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This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.

Official Title
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BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study

Conditions
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Pediatrics, Muscle Spasticity, Cerebral Palsy

Intervention / Treatment
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* Biological: Botulinum Toxin Type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum weight of 10 kilograms (kg)/22 pounds (lb) Cerebral palsy with dynamic muscle contracture of the ankle Exclusion Criteria: Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease Uncontrolled epilepsy Botulinum Toxin therapy of any serotype for any condition within the last 3 months History of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX®<br>Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study. | Biological: Botulinum Toxin Type A<br>* Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.<br>* Other names: OnabotulinumtoxinA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. | From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks) |