Clinical trial NCT02188277: Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Spastic Paraplegia and Hemiparesis
Equine and Equinovarus Foot Deformation
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
Collaborators: name: LLC Merz Pharma, Russia
First posted: 2014-07-11
Enrollment: 64
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
timeFrame: From baseline to day 30
Secondary outcomes:
measure: Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale
timeFrame: From baseline up to day 90
measure: Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values
timeFrame: From baseline up to day 90
measure: Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior
timeFrame: From baseline up to day 90
measure: Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension
timeFrame: From baseline up to day 90
measure: Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria
timeFrame: From baseline up to day 90
measure: Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale
timeFrame: Baseline up to day 90
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department"
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation
city: Stavropol
country: Russian Federation
facility: Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation
Study officials:
affiliation: LLC Merz Pharma, Russia
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: