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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Cerebral Palsy Spastic Paraplegia and Hemiparesis Equine and Equinovarus Foot Deformation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xeomin®

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

Group Type EXPERIMENTAL

Xeomin

Intervention Type 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.

Botox®

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

Group Type ACTIVE_COMPARATOR

Botox®

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Botox®

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No