Dysport® Pediatric Lower Limb Spasticity Study

Ipsen241 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

241

Conditions

Cerebral Palsy Muscle Spasticity Children

Interventions

Botulinum toxin type ABIOLOGICAL

I.M. (in the muscle) injection on day 1 of a single treatment cycle.

PlaceboDRUG

I.M. injection on day 1 of a single treatment cycle.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (29)

Outcomes

Primary Outcomes

Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb

The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).

Time frame: Change from baseline to Week 4

Secondary Outcomes

Physician's Global Assessment (PGA) of the Treatment Response.

PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: "how would you rate the response to treatment in the subject's lower limb(s) since the last injection?" Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).

Time frame: Week 4

Goal Attainment Scale (GAS) Score

GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).

Time frame: Week 4

Data from ClinicalTrials.gov

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