The name of the study: is a double-blind comparative randomized trial to evaluate the safety and efficacy of the drug Miotox® with the participation of children with cerebral palsy The code/number of the Protocol No. MTK-III-D-cerebral palsy-04/2019, version 5.0 dated 09/01/2021.
Investigational drug Trade Name: Miotox®. Description: Transparent or slightly opalescent liquid from colorless to light yellow. Manufacturer: FSBI "M.P. Chumakov FNCRIP RAS", Russia Comparison drug: Trade Name: Botox® Description: dried white substance in the form of a barely noticeable film located at the bottom of the bottle. Manufacturer: Allergan Pharmaceuticals Ireland, Ireland.
The studied indication for use is Focal spasticity associated with dynamic foot deformity of the "horse foot" type due to spasticity in patients 2 years and older with cerebral palsy who are on outpatient treatment Study design Double-blind comparative randomized multicenter The sponsor of the study is Innopharm LLC, Russia Clinical Development: Phase III The start date of the study is 10/15/2021. The date of completion of the study is 06/29/2022.
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:
All patients were checked for compliance with the following inclusion criteria:
* Written and dated Informed consent of the child's parent to participate in the clinical trial; The age of the child is from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days);
* Focal spasticity associated with dynamic foot deformity of the "horse foot" type due to spasticity in children with cerebral palsy undergoing outpatient treatment;
* The degree of spasticity on the modified Ashworth scale (MAS) 2 or more;
* Grade level on the scale of basic motor functions for cerebral palsy, extended and refined version (GMFCS - E\&R) I - III;
* Children and their parents who are able to fulfill the requirements of the Protocol (i.e., fill out a self-observation diary, come to control visits).
Exclusion Criteria:
During the study, patients were excluded if any of the following criteria were present:
* Withdrawal of Informed consent by the patient's parent;
* Serious adverse events or adverse events that do not meet the criteria of severity, in the development of which, in the opinion of the researcher, further participation in the study may be detrimental to the health or well-being of the patient;
* The need for procedures and/or drug treatment that are not permitted by the Protocol of this study;
* The patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol;
* The appearance of non-inclusion criteria during the study;
* T…
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.