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OpenTrials
Completed

NCT Number: NCT02188277

Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy

1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy 2. To assess the safety of Xeomin® use as compared to Botox® in this patient population

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Equine and Equinovarus Foot Deformation Nervous System Diseases Neurologic Manifestations Paralysis Paraplegia Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Paraplegia and Hemiparesis

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children from 2 through 12 years of age, of both sexes, suffering from spastic paraplegia or hemiparesis in pediatric cerebral palsy.
  • Equine and equinovarus foot posture.
  • Gastrocnemius spasticity of 2 points and greater, by modified Ashworth scale.
  • Patient can walk unassisted or with a support.
  • Mental development of patients is normal or mildly retarded.
  • Previous course of spasticity treatment with BTA products was completed earlier than at 6 months before this trial or never administered before.
  • Patient's parents have signed an informed consent, are able and wishing to adhere to procedures described in the trial protocol and to the schedule of visits throughout the entire period of treatment.

Exclusion criteria

  • Fixed ankle joint contracture.
  • Previous denervation of spastic muscles by surgery, phenol or alcohol;
  • Athetosis and dystonia in the area of injected muscles.
  • Inflammation at the planned injection site.
  • Elevated body temperature and acute (infectious and non-infectious) diseases at the time of injection.
  • Neuromuscular transmission disorders (myasthenia gravis, Lambert-Eaton syndrome, etc.).
  • Decompensated physical diseases potentially affecting the trial findings.
  • Acute fever, infection or surgery within 1 month before the trial.
  • Use of aminoglycosides or spectinomycin within 1 month before starting the trial.
  • Hypersensitivity to any of product ingredients.
  • Positive history for allergies (especially with regard to protein-containing products).
  • Patient's parents are unable or unwilling to adhere to the trial protocol requirements including signing the informed consent and conforming to the schedule of visits.
  • Participation in other clinical trials in the last 4 weeks before inclusion.

Treatment and study plan

Xeomin

Drug

Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.

Other names: IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Botox®

Drug

Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.

Other names: OnabotulinumtoxinA

Primary outcomes

  1. Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)

    Time frame: From baseline to day 30

    The AS is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Secondary outcomes

  1. Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale

    Time frame: From baseline up to day 90

  2. Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values

    Time frame: From baseline up to day 90

    Electromyography: The amplitude of a compound muscle action potential (M-wave) is recorded. An electrical stimulation is considered supramaximal when the M-wave amplitude no longer increases while increasing the stimulus. The measurements include the M-wave amplitude and the negative peak area of the M-wave.

  3. Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior

    Time frame: From baseline up to day 90

  4. Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension

    Time frame: From baseline up to day 90

  5. Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria

    Time frame: From baseline up to day 90

    GMFCS is a 5-level classification system that is a standardized observational instrument for children with CP developed to measure change in gross motor function over time.

  6. Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale

    Time frame: Baseline up to day 90

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Collaborators

  • LLC Merz Pharma, Russia

Registry information

Official study title

Multi-center Open Comparative Randomized Trial of Clinical and Neurophysiological Efficacy and Safety of Xeomin (Botulinum Toxin Type A) vs. Botox (Complex of Botulinum Toxin Type A and Hemagglutinin) in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy

Acronym: XEBEC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2014
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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