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

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ClinicalTrials.gov Identifier: NCT01276015
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy and Botulinum Toxin Drug: Botulinum Toxin Type A Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SPREAD AND EFFECTIVENESS OF BOTULINUM NEUROTOXIN A IN SPASTIC EQUINUS IN CEREBRAL PALSY:SHORT-TERM STUDY
Study Start Date : December 2009
Primary Completion Date : February 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: dysport, ipsen


Outcome Measures

Primary Outcome Measures :
  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 [ 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   25 Months to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276015


Sponsors and Collaborators
Universita di Verona
Investigators
Study Director: laura bertolasi, md Universita di Verona
More Information

Responsible Party: manager en-chief dr Caffi
ClinicalTrials.gov Identifier: NCT01276015     History of Changes
Other Study ID Numbers: CE1780
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: November 2009

Keywords provided by Universita di Verona:
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

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents