Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformati… (NCT02188277) | Clinical Trial Compass
CompletedPhase 2
Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
Russia64 participantsStarted 2014-07
Plain-language 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
Who can participate
Age range2 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)