BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity

Allergan

Status and phase: Completed; Phase 3

Conditions: Pediatrics; Stroke; Cerebral Palsy; Muscle Spasticity

Treatments: Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01603615

191622-105

2012-000043-27 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum weight of 10 Kilograms (kg) / 22 Pounds (lb)
• Upper limb spasticity due to cerebral palsy or stroke

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 upper limb 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)

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220 participants in 1 patient group

BOTOX®

Experimental group

Description:

Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study.

Treatment:

Biological: Botulinum Toxin Type A