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

NCT02188277 | Completed Phase 2

• 1 other identifier: MRZ-R-201212_01001_N_2
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

1. 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. 2.To assess the safety of Xeomin® use as compared to Botox® in this patient population

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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).

  From baseline to day 30

Secondary Outcomes (6)

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

  From baseline up to day 90

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

  From baseline up to day 90

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

  From baseline up to day 90

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

  From baseline up to day 90

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

  From baseline up to day 90

Study Arms (2)

Xeomin®

EXPERIMENTAL

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

Drug: Xeomin

Botox®

ACTIVE COMPARATOR

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

Drug: Botox®

Interventions

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.

Also known as: IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Xeomin®

Botox® DRUG

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

Also known as: OnabotulinumtoxinA

Botox®

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead
• LLC Merz Pharma, Russia: collaborator

Study Sites (3)

State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department"

Moscow, 119602, Russia

Location

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

Moscow, 119991, Russia

Location

Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation

Stavropol, 355017, Russia

Location

MeSH Terms

Conditions

Cerebral Palsy; Paraplegia; Paresis

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Merz Medical Expert

  LLC Merz Pharma, Russia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

RU (3)