80
Participants
Start Date
October 15, 2021
Primary Completion Date
May 15, 2022
Study Completion Date
June 29, 2022
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®."
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®."
"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
Lead Sponsor
Innopharm LLC
INDUSTRY