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 range
2 Years – 12 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)