BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

Allergan

Status and phase: Completed; Phase 3

Conditions: Pediatrics; Cerebral Palsy; Muscle Spasticity

Treatments: Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01603641

2012-000084-24 (EudraCT Number)

191622-112

Details and patient eligibility

About

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

Enrollment: 370 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

370 participants in 1 patient group

BOTOX®

Experimental group

Description:

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.

Treatment:

Biological: Botulinum Toxin Type A