BOTOX® 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; Drug: Normal Saline (Placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01603628

2012-000042-35 (EudraCT Number)

191622-111

Details and patient eligibility

About

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

Enrollment: 384 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum weight of 10 kg/22 lb
• Cerebral palsy with dynamic muscle contracture /spasticity 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 6 months
• History of surgical intervention of the lower study leg or planned surgery of any limb during the study
• Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected upper limb during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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384 participants in 3 patient groups, including a placebo group

BOTOX® 4 U/kg

Experimental group

Description:

Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).

Treatment:

Biological: botulinum toxin Type A

BOTOX® 8 U/kg

Experimental group

Description:

Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.

Treatment:

Biological: botulinum toxin Type A

Normal Saline (Placebo)

Placebo Comparator group

Description:

Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1. Participants received weekly PT.

Treatment:

Drug: Normal Saline (Placebo)