Publications by authors named "V A Dudin"
[Safety and efficacy of Relatox in comparison with Dysport in the treatment of focal spasticity of the upper limb in patients after stroke and traumatic brain injury (results of a prospective simple blind randomized comparative study in parallel groups)].
Zh Nevrol Psikhiatr Im S S Korsakova
December 2024
Article Synopsis
- The study aimed to evaluate the safety and effectiveness of Relatox, a type of botulinum toxin, in treating focal spasticity of the upper limb caused by cerebrovascular accidents or traumatic brain injuries.
- It involved 210 patients divided into two groups; one received Relatox injections, while the other received Dysport. Both groups showed a reduction in spasticity over 12 weeks, with no significant differences between the two treatments.
- Various measurements were used to assess spasticity, disability, pain, and treatment satisfaction, and both medications were found to be effective, with a report on adverse events collected throughout the study.
[Long-term efficacy and safety of divozilimab during 2-year treatment of multiple sclerosis patients in randomized double-blind placebo-controlled clinical trial BCD-132-4/MIRANTIBUS].
Zh Nevrol Psikhiatr Im S S Korsakova
April 2024
Objective: To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg every 24 weeks during 100 weeks for the treatment of patients with multiple sclerosis (MS), including relapsing-remitting multiple sclerosis (RRMS) and secondary progressive MS (SPMS) with relapses.
Material And Methods: The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS (NCT05385744) included 338 adult patients with MS distributed in a 1:1 ratio into two groups: DIV 500 mg and teriflunomide (TRF) 14 mg. After screening, subjects were included in the main CT period, which consisted of two cycles of therapy over 48 weeks, then entered an additional period from weeks 49 to 100, which included three cycles of therapy.
Objective: To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) in comparison with the teriflunomide (TRF). The study of the efficacy and safety of the use of the drug DIV was carried out for 48 weeks of therapy.
Material And Methods: The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS included 338 adult patients with RRMS distributed in a 1:1 ratio into two groups: DIV 500 mg and TRF 14 mg.
Article Synopsis
- A clinical trial assessed the effectiveness and safety of sampeginterferon-β1a (samPEG-IFN-β1a) given every two weeks for relapsing-remitting multiple sclerosis, comparing it to placebo and low-dose interferon beta-1a (LIB).
- After 104 weeks, the samPEG-IFN-β1a groups showed low relapse rates (0.16 and 0.09) and high percentages of relapse-free patients (77.0% and 83.3%).
- The treatment was found to have a consistent safety profile, making samPEG-IFN-β1a a promising first-line therapy for this type of multiple sclerosis.
Objective: To evaluate the efficacy and safety of samPEG-IFN-β1a 180 μg and 240 μg administered once every 2 weeks for the treatment of relapsing remitting multiple sclerosis (RRMS) compared to placebo and low dose interferon beta-1a (LIB) 30 μg administered once weekly. The primary endpoint after 52 weeks of therapy was the time to first relapse, the hypotheses of non-inferiority and superiority to LIB were tested.
Material And Methods: This international, multicenter, double blind, comparative, placebo-controlled clinical study enrolled 399 patients with the diagnosis of RRMS, randomized in 4 groups: samPEG-IFN-β1a180 μg (=114), samPEG-IFN-β1a 240 μg (=114), LIB (=114) and placebo (=57).