Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy

January 18, 2011 updated by: Universita di Verona

SPREAD AND EFFECTIVENESS OF BOTULINUM NEUROTOXIN A IN SPASTIC EQUINUS IN CEREBRAL PALSY:SHORT-TERM STUDY

Objectives. To study the short-term neurophysiological and clinical outcome of botulinum toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring uninjected muscles in children with cerebral palsy.

Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical scales were assessed and video gait was analyzed at all three time points.

Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side decreased significantly from pre-injection values at T10 (p<0.05) and T30 (p<0.002). Assessment at both time points after injections also showed that ankle spasticity had diminished (p<0.05), equinus foot excursion increased (p<0.05), and functional gait improved (p<0.05).

Conclusion. Although BoNT-A injected at standard doses improves gait in children with spastic equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for cerebral palsy therefore needs individualizing according to the child's clinical features.

Study Overview

Status

Status

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Completed

Conditions

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Intervention / Treatment

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Interventional

Enrollment (Actual)

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18

Phase

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  • Phase 4

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Ages Eligible for Study

2 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spasticity refractory to oral medication
  • patients able to walk independently or with aid
  • no contraindications to BoNT-A treatment such as fixed contracture,aminoglycoside therapy and myasthenia gravis and no other neuromuscular diseases
  • no orthopedic surgery before
  • normal or mildly declined cognition
  • previous treatment at least six months before the study

Exclusion Criteria:

  • all contraindications to BoNT-A treatment

Study Plan

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How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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Intervention / Treatment

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Experimental: botulinum toxin A
botulinum toxin A diffusion in cerebral palsy
Drug: Botulinum Toxin Type A
BoNT-A (Dysport, Ipsen) ,into the medial gastrocnemius (MG) and LG muscles unilaterally on the affected spastic hemiplegic side; dose mean± SE, 283.3± 24.7 U.. The mean dose/kg injected was 14.4± 0.8, range from 8.5 to 20 U/kg, diluted in 2.5 ml saline. frequency: once.
Other Names:
  • dysport, ipsen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

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Outcome Measure
Measure Description
Time Frame
BoNT-A injected into gastrocnemius within standard dose ranges spreads to surrounding anterior lower-limb muscles in children with CP and induces chemodenervation in injected muscles
Time Frame: one month
As the primary neurophysiological outcome measure of BoNT-A induced paresis and spread, we studied changes in compound muscle action potential (CMAP) areas recorded from the lateral gastrocnemius (LG) muscle after injecting BoNT-A and from the ipsilateral tibialis anterior (TA) muscle in children with spastic hemiplegia. In line with others we considered a decreased CMAP area from LG muscle injected with BoNT-A as the neurophysiological index of BoNT-A-induced paresis
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP
Time Frame: 30 days
As the clinical outcome measures clinical scales were assessed and video gait was analyzed before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections.
30 days

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Sponsor

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Universita di Verona

Investigators

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  • Study Director: laura bertolasi, md, Universita di Verona

Study record dates

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Study Major Dates

Study Start

Study Start

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December 1, 2009

Primary Completion (Actual)

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February 1, 2010

Study Completion (Actual)

Study Completion

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May 1, 2010

Study Registration Dates

First Submitted

First Submitted

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January 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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January 12, 2011

First Posted (Estimate)

First Posted

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January 13, 2011

Study Record Updates

Last Update Posted (Estimate)

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January 19, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

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January 18, 2011

Last Verified

Last Verified

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November 1, 2009

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Other Study ID Numbers

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  • CE1780

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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