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

Merz Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Cerebral Palsy

Spastic Paraplegia and Hemiparesis

Equine and Equinovarus Foot Deformation

Treatments

Drug: Xeomin

Drug: Botox®

Study type

Interventional

Funder types

Industry

Other

Identifiers

MRZ-R-201212_01001_N_2

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No 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.