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

Primary Purpose

Cerebral Palsy, Spastic Paraplegia and Hemiparesis, Equine and Equinovarus Foot Deformation

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Xeomin
Botox®
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department"
  • Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation
  • Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xeomin®

Botox®

Arm Description

4-8 Units per kg body weight. Single injection cycle.

4-6(8) Units per kg body weight. Single injection cycle.

Outcomes

Primary Outcome Measures

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

Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale
Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values
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.
Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior
Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension
Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria
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.
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale

Full Information

First Posted
July 10, 2014
Last Updated
January 25, 2017
Sponsor
Merz Pharmaceuticals GmbH
Collaborators
LLC Merz Pharma, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT02188277
Brief Title
Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
Acronym
XEBEC
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
Collaborators
LLC Merz Pharma, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic Paraplegia and Hemiparesis, Equine and Equinovarus Foot Deformation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xeomin®
Arm Type
Experimental
Arm Description
4-8 Units per kg body weight. Single injection cycle.
Arm Title
Botox®
Arm Type
Active Comparator
Arm Description
4-6(8) Units per kg body weight. Single injection cycle.
Intervention Type
Drug
Intervention Name(s)
Xeomin
Other Intervention Name(s)
IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Botox®
Other Intervention Name(s)
OnabotulinumtoxinA
Intervention Description
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Primary Outcome Measure Information:
Title
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
Description
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).
Time Frame
From baseline to day 30
Secondary Outcome Measure Information:
Title
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
Title
Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values
Description
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.
Time Frame
From baseline up to day 90
Title
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
Title
Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension
Time Frame
From baseline up to day 90
Title
Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria
Description
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.
Time Frame
From baseline up to day 90
Title
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale
Time Frame
Baseline up to day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
LLC Merz Pharma, Russia
Official's Role
Study Director
Facility Information:
Facility Name
State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department"
City
Moscow
ZIP/Postal Code
119602
Country
Russian Federation
Facility Name
Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation

12. IPD Sharing Statement

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

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