NCT06840158

Double-blind Comparative Randomized Multicenter

A Double-blind Comparative Randomized Trial to Evaluate the Safety and Efficacy of the Drug Miotox® in Children with Cerebral Palsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Innopharm LLC · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy (CP)

Interventions

Type	Name	Description
DRUG	Miotox (Botulinum toxin type A is a hemagglutinin complex)	During the study, patients were injected with the investigational drug Miotox® . For the treatment of spasticity and equine varus deformity of the foot in children with cerebral palsy, drugs were injected into two points of each head of the calf muscle (medial and lateral). In case of damage to one limb, the total dose was 4 units / kg of body weight per affected limb. In diplegia, the total dose was 6 units / kg of body weight for both affected limbs. The total total dose should not exceed 200 units. This course of treatment is based on the current instructions for the medical use of Botox®.
DRUG	BOTOX®	During the study, patients were injected with the investigational comparison drug Botox®. For the treatment of spasticity and equine varus deformity of the foot in children with cerebral palsy, drugs were injected into two points of each head of the calf muscle (medial and lateral). In case of damage to one limb, the total dose was 4 units / kg of body weight per affected limb. In diplegia, the total dose was 6 units / kg of body weight for both affected limbs. The total total dose should not exceed 200 units. This course of treatment is based on the current instructions for the medical use of Botox®.

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-05-15
• Completion: 2022-06-29
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

3 sites across 1 country: Russia