Double-blind Comparative Randomized Multicenter

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 15, 2021

Primary Completion Date

May 15, 2022

Study Completion Date

June 29, 2022

Conditions
Cerebral Palsy (CP)
Interventions
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®."

Trial Locations (3)

Unknown

"SPb GBUZ DGP No. 45 of the Nevsky district", Saint Petersburg

GBUZ SODKB named after N.N. Ivanova, Candidate of Medical Sciences;, Samara

"Limited Liability Company Santerra (LLC Santerra)", Stavropol

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Innopharm LLC

INDUSTRY