Clinical trial NCT06840158: Double-blind Comparative Randomized Multicenter
Official title: A Double-blind Comparative Randomized Trial to Evaluate the Safety and Efficacy of the Drug Miotox® in Children with Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Palsy (CP)
Keywords: botulinum toxin
Lead sponsor: Innopharm LLC
Sponsor class: INDUSTRY
First posted: 2025-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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;
* The need for surgical intervention.
* The patient's incompetence with the examination procedures.
* Any condition of the patient that requires, in the reasonable opinion of the research physician, the withdrawal of the patient from the study;
* The patient refuses to cooperate or is undisciplined (for example, the patient does not show up for a scheduled visit without warning the researcher and/or loss of communication with the patient);
* The patient is out of observation;
* Non-compliance by the patient with the established Protocol requirements, rules of stay at the clinical base; For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.

Primary outcomes:
measure: Safety assessment
timeFrame: 14 weeks
measure: Efficasy assessment
timeFrame: 14 weeks
Secondary outcomes:
measure: Safety assessment
timeFrame: 14 weeks
measure: Safety assessment
timeFrame: 14 weeks
measure: Safety assessment
timeFrame: 14 weeks
measure: Efficasy assessment
timeFrame: 14 weeks
measure: Efficasy assessment
timeFrame: 14 weeks
measure: Efficasy assessment
timeFrame: 14 weeks
measure: Efficasy assessment
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: SPb GBUZ "DGP No. 45 of the Nevsky district
city: Samara
country: Russian Federation
facility: GBUZ SODKB named after N.N. Ivanova, Candidate of Medical Sciences;
city: Stavropol
country: Russian Federation
facility: Limited Liability Company "Santerra" (LLC "Santerra")
Study officials:
References: