Dysport® Pediatric Lower Limb Spasticity Study

Ipsen

Status and phase: Completed; Phase 3

Conditions: Cerebral Palsy; Children; Muscle Spasticity

Treatments: Drug: Placebo; Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01249417

Y-55-52120-141

2009-017709-12 (EudraCT Number)

Details and patient eligibility

About

The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.

Enrollment: 241 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 2 to 17 years with cerebral palsy
• Equinus foot position
• Ambulatory
• Intensity of muscle tone equal to or greater than 2 in affected lower limb, as measured on the Modified Ashworth Scale

Exclusion criteria

• Fixed contracture
• Previous phenol, alcohol injection or surgical intervention
• Other neurological / neuromuscular disorder
• Severe athetoid or dystonic movements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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241 participants in 3 patient groups, including a placebo group

Dysport 10 U/Kg

Experimental group

Description:

10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.

Treatment:

Biological: Botulinum toxin type A

Dysport 15 U/Kg

Experimental group

Description:

15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.

Treatment:

Biological: Botulinum toxin type A

Placebo

Placebo Comparator group

Description:

Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.

Treatment:

Drug: Placebo