BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

Phase 3

Completed

• Conditions: Muscle Spasticity; Cerebral Palsy; Pediatrics

• Registration Number: NCT01603641
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-22
• Study Start: 2012-11-05
• Primary Completion: 2018-08-25
• Study Completion: 2018-08-25
• Status Verified: 2019-07
• Results First Submitted: 2019-07-29
• Results First Submitted QC: 2019-07-29
• Last Update Submitted: 2019-07-29
• Results First Posted: 2019-08-21
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)	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.

Trial Locations

Locations (56)

ABS Health, LLC; 🇺🇸 Pasadena, California, United States

Harrison Clinical Management; 🇺🇸 Pomona, California, United States

Rady Children's Hospital San Diego; 🇺🇸 San Diego, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Associated Neurologists of Southern Connecticut, P.C.; 🇺🇸 Fairfield, Connecticut, United States

New England Institute for Clinical Research; 🇺🇸 Stamford, Connecticut, United States

NW FL Clinical Research Group, LLC; 🇺🇸 Gulf Breeze, Florida, United States

Axcess Medical Research, LLC; 🇺🇸 Loxahatchee Groves, Florida, United States

Pediatric Neurology, P.A.; 🇺🇸 Orlando, Florida, United States

Children's Healthcare of Atlanta Children's Rehabilitation Associates; 🇺🇸 Atlanta, Georgia, United States

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