Delving into the Latest Updates on S-100 protein antibody(Materia Medica Holding) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Tenoten

Target-

Action-

Mechanism-

Therapeutic Areas

Other Diseases

Active Indication

Anxiety Disorders

Inactive Indication

Brain InjuriesLearning Disabilities

Originator Organization

OOO NPF Materia Medica Holding

Active Organization

OOO NPF Materia Medica Holding

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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The purposes of this study are:
To further examine the efficacy and safety of Tenoten® in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders.
To compare the efficacy of two dosing regimens of Tenoten® (4 tablets daily vs.8 tablets daily, both for 12 weeks) in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders.

Start Date08 Feb 2017

Sponsor / Collaborator

OOO NPF Materia Medica Holding

NCT03159611

/ CompletedPhase 3

Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury

Purpose of the study:
To assess the clinical efficacy of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial haemorrhage).
To assess the safety of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial haemorrhage).

Start Date19 Feb 2016

Sponsor / Collaborator

OOO NPF Materia Medica Holding

NCT03159104

/ CompletedPhase 3

Multicenter Double-blind Placebo-Controlled Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children

Purpose of the study:
• To evaluate efficacy and safety of Tenoten for children in the treatment of specific developmental disorders of scholastic skills in children.

Start Date25 Aug 2015

Sponsor / Collaborator

OOO NPF Materia Medica Holding

100 Clinical Results associated with S-100 protein antibody(Materia Medica Holding)

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100 Translational Medicine associated with S-100 protein antibody(Materia Medica Holding)

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100 Patents (Medical) associated with S-100 protein antibody(Materia Medica Holding)

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24

Literatures (Medical) associated with S-100 protein antibody(Materia Medica Holding)

01 Jan 2024·S.S. Korsakov Journal of Neurology and Psychiatry

Anxiety disorders as comorbid conditions in neuropsychiatric diseases in children

Review

Author: Zavadenko, N N ; Zavadenko, A N ; Shypilova, E M ; Nesterovskiy, Yu E

The variants of heterotypic comorbidity of anxiety disorders (AD) with attention deficit hyperactivity disorder, autism spectrum disorders, speech and language development disorders, specific learning disabilities (dyslexia, dysgraphia, dyscalculia), migraine, tension type headache in children and adolescents are discussed. In cases of heterotypic comorbidity the patients with AD referrals to specialists may be primarily associated with their emotional problems. Meanwhile, the comorbidity of AD with these diseases leads to a deterioration of their clinical manifestations and a worsening of the prognosis, and anxiety symptoms often not only persist, but also increase with age. It should be borne in mind that AD in children with neurodevelopmental disorders contribute to a decrease in the quality of life, academic failure, have a negative impact on peer relationships and the family environment, and in young adulthood, patients have an increased risk of depression and substance abuse. Therefore, early intervention and a comprehensive therapeutic approach with a dynamic assessment of the patient's condition are becoming important. When choosing pharmacotherapy, it is advisable to choose medictions that have a complex effect on the pathogenetic mechanisms of the underlying disease and concomitant AD, which include Tenoten for children.

01 Jan 2021·Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova

Neurodevelopmental disorders in children and the possibilities of their pharmacotherapy

Article

Author: Fateeva, V V ; Zavadenko, N N ; Zavadenko, A N ; Suvorinova, N Yu

Neurodevelopmental disorders (NDD) are characterized by disturbances of the formation of cognitive functions, communication skills, behavior characteristics and/or motor skills, which are caused by abnormalities in the course of the processes of neuroontogenesis. In the clinical practice of a pediatric neurologist and pediatrician, a significant part consists of patients with NDD without a general decrease in intelligence, primarily with speech development disorders, attention deficit hyperactivity disorder (ADHD), specific learning disorders (dyslexia, dysgraphia, dyscalculia). NDD represent a heterogeneous group of diseases, having multifactorial origin and a neurobiological nature, which are caused by genetic mechanisms and early (perinatal) brain damage. Among children with NDD, there is a higher occurrence of anxiety disorders compared to their peers. With NDD, early intervention is indicated, and its positive effect is possible during the period when the brain is most plastic and capable of changes. The published results of multicenter, double-blind, placebo-controlled, randomized clinical trials of pharmacotherapy with the medication "Tenoten for children" for ADHD, specific learning disorders, anxiety disorders and the consequences of perinatal damage to the central nervous system are reviewed.

01 Jan 2020·Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova

Developmental disorders of academic skills in children: the efficacy and safety of Tenoten for children in the multicenter double-blind placebo-controlled randomized study

Article

Author: Khaletskaya, O V ; Suvorinova, N Yu ; Sagautdinova, E Sh ; Zavadenko, N N ; Teplyakova, E D ; Antonova, T I ; Doronina, O B ; Gaynetdinova, D D ; Boychevskaya, Yu O ; Panteleeva, M V ; Skripchenko, N V

OBJECTIVETo evaluate the efficacy and safety of tenoten for children in the treatment of specific developmental disorders of academic skills in children of 1-3 grades.MATERIAL AND METHODSTwo hundred and forty children, aged 7-9 years, (Total set, Safety population) with verified specific reading disorder (F81.0), specific spelling disorder (F81.1), specific disorder of arithmetical skills (F81.2), mixed disorder of scholastic skills (F81.3; F81.2+F81.0, or F81.2+F81.1, or F81.2+F81.0+F81.1), diagnosed with the use of logopedic or psychological testing (15-35 scores in Fotekova T.A. and Akhutina T.V. reading and writing tests; 5-15 scores in arithmetical subscale of the Wechsler Intelligence Scale for Children) were enrolled in the study. CT was conducted in 10 clinical centers in Russian Federation in 2015- 2019. Patients were randomized into two groups. The first one (n=122) received tenoten for children in a dose of 1 tablet 3 times a day, the second one (n=118) was administered placebo in the same dosage regimen. The clinical data on 237 children (121 of the tenoten group and 116 of the placebo group) were used for Intention-to-treat efficacy analysis. Data on 220 children (115 of the tenoten group and 105 of the placebo group) were included in Per-protocol analysis. The duration of study was 12 weeks. The mean total academic skills (reading, spelling, and counting) score in groups after 12 weeks of treatment was set as the primary efficacy endpoint.RESULTSThe mean total academic skills score increased by 18.55±15.87 points. The significant total difference between the median changes in the total score in the tenoten and placebo groups was 5 points. There was a trend towards positive changes in reading and spelling mean scores in tests that didn't reach statistical significance due to lack of normal distribution of points in samples. There were 73 adverse events (AEs) in 42 patients of the tenoten group and 95 AEs in 31 children of the placebo group. No serious or severe AEs were registered in the tenoten group. No AEs definitely related to the study treatment were registered. No negative drug interactions were observed in the tenoten group.CONCLUSIONSTenoten for children is an effective and safe treatment for specific developmental disorders of academic skills in primary school children. Tenoten for children is well tolerated. The treatment is characterized by a high level of adherence of children and their parents to therapy.

100 Deals associated with S-100 protein antibody(Materia Medica Holding)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Anxiety Disorders	Russia	OOO NPF Materia Medica Holding	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Brain Injuries	Phase 1	Russia	OOO NPF Materia Medica Holding	19 Feb 2016
Learning Disabilities	Phase 1	Russia	OOO NPF Materia Medica Holding	25 Aug 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03159104 (CTgov)	Phase 3	Learning Disabilities	240	Tenoten for children (Tenoten for Children)	zznzbtiyfm(vmfvnqlsvy) = juvoeqxguf jwbpjnkxgm (kjvlckmlmr, mrruwduumz - xabpqgtmfe) View more	-	21 Aug 2023
				Placebo (Placebo)	zznzbtiyfm(vmfvnqlsvy) = sftadvvmen jwbpjnkxgm (kjvlckmlmr, pjmhkkivdb - xcmmbtayzf) View more
NCT03036293 (CTgov)	Phase 4	Anxiety Disorders	390	Tenoten (Tenoten, 2 Tablets Twice Daily (4 Tablets/Day))	myhgmngkpr(obxcogqkfv) = jyksjgxuqo umogncvydy (whkceyqilp, svfuphykly - kdekusxivn) View more	-	31 Dec 2020
				Tenoten (Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day))	myhgmngkpr(obxcogqkfv) = neyvexpoom umogncvydy (whkceyqilp, upozsfhavw - ffzkxpfzlo) View more
NCT03159611 (CTgov)	Phase 3	Brain Injuries	182	Tenoten for children (Tenoten for Children)	tfhkacoawz(drynwcoytt) = voxgegndlc usyrsxiymw (pjmepwvcse, klmkmnvsqn - tpuquelxqm) View more	-	08 Apr 2019
				Placebo (Placebo)	tfhkacoawz(drynwcoytt) = uenzeaxqus usyrsxiymw (pjmepwvcse, hjtwhjsvuo - giiqapkwjt) View more

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