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

NCT01276015 | Completed Phase 4 DMC

• 1 other identifier: CE1780
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Palsy and Botulinum Toxin

Keywords

BoNT-A-botulinum neurotoxin type A; CMAP-compound muscle action potential; CP-cerebral palsy; LG-lateral gastrocnemius; MG-medial gastrocnemius; TA-tibialis anterior; PROMS-passive range of movement; MAS-modified Ashworth scale; EVGS-Edinburgh visual gait scale; GMF-CS-gross motor function classification system

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

• the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP

  30 days

Study Arms (1)

botulinum toxin A

EXPERIMENTAL

botulinum toxin A diffusion in cerebral palsy

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

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.

Also known as: dysport, ipsen

botulinum toxin A

Eligibility Criteria

• Age: 25 Months - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• all contraindications to BoNT-A treatment

Sponsors & Collaborators

• Universita di Verona: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• laura bertolasi, md

  Universita di Verona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 13, 2011
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 19, 2011

Record last verified: 2009-11