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

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ClinicalTrials.gov Identifier: NCT02188277
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
LLC Merz Pharma, Russia
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Brief Summary:
  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

Condition or disease Intervention/treatment Phase
Cerebral Palsy Spastic Paraplegia and Hemiparesis Equine and Equinovarus Foot Deformation Drug: Xeomin Drug: Botox® Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Xeomin®
4-8 Units per kg body weight. Single injection cycle.
Drug: Xeomin

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

Active Comparator: Botox®
4-6(8) Units per kg body weight. Single injection cycle.
Drug: Botox®
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Other Name: OnabotulinumtoxinA




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02188277


Locations
Russian Federation
State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department"
Moscow, Russian Federation, 119602
Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation
Moscow, Russian Federation, 119991
Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation
Stavropol, Russian Federation, 355017
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
LLC Merz Pharma, Russia
Investigators
Study Director: Merz Medical Expert LLC Merz Pharma, Russia

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT02188277     History of Changes
Other Study ID Numbers: MRZ-R-201212_01001_N_2
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Paresis
Paraplegia
Clubfoot
Talipes
Equinus Deformity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Paralysis
Foot Deformities, Acquired
Foot Deformities
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA