S-100 protein antibody(Materia Medica Holding)(S-100 protein antibody(Materia Medica Holding))

概要

基本信息

药物类型

单克隆抗体

别名

Tenoten

靶点-

作用方式-

作用机制-

治疗领域

其他疾病

在研适应症

焦虑症

非在研适应症

脑损伤学习障碍

原研机构

OOO NPF Materia Medica Holding

在研机构

OOO NPF Materia Medica Holding

非在研机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 S-100 protein antibody(Materia Medica Holding) 相关的临床试验

NCT03036293

/ Completed临床4期

International Multicenter, Double-blind, Randomized Placebo-controlled Phase IV Clinical Trial of Different Dosing Regimens of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders

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.

开始日期2017-02-08

申办/合作机构

OOO NPF Materia Medica Holding

NCT03159611

/ Completed临床3期

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).

开始日期2016-02-19

申办/合作机构

OOO NPF Materia Medica Holding

NCT03159104

/ Completed临床3期

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.

开始日期2015-08-25

申办/合作机构

OOO NPF Materia Medica Holding

100 项与 S-100 protein antibody(Materia Medica Holding) 相关的临床结果

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100 项与 S-100 protein antibody(Materia Medica Holding) 相关的转化医学

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100 项与 S-100 protein antibody(Materia Medica Holding) 相关的专利（医药）

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24

项与 S-100 protein antibody(Materia Medica Holding) 相关的文献（医药）

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

Anxiety disorders as comorbid conditions in neuropsychiatric diseases in children

Review

作者: 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.

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

Neurodevelopmental disorders in children and the possibilities of their pharmacotherapy

Article

作者: 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.

2020-01-01·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

作者: 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 项与 S-100 protein antibody(Materia Medica Holding) 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
焦虑症	俄罗斯	OOO NPF Materia Medica Holding	-

未上市

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适应症	最高研发状态	国家/地区	公司	日期
脑损伤	临床1期	俄罗斯	OOO NPF Materia Medica Holding	2016-02-19
学习障碍	临床1期	俄罗斯	OOO NPF Materia Medica Holding	2015-08-25

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03159104 (CTgov)	临床3期	学习障碍	240	Tenoten for children (Tenoten for Children)	蓋製構壓鏇觸簾襯築鏇(艱積繭膚齋壓遞艱製遞) = 製窪鏇憲壓廠艱網衊築鏇選製繭獵顧鏇糧廠憲 (糧衊積構構襯範觸選餘, 遞選網膚顧觸範構製憲 ~ 簾簾鏇艱淵淵願築壓簾) 更多	-	2023-08-21
				Placebo (Placebo)	蓋製構壓鏇觸簾襯築鏇(艱積繭膚齋壓遞艱製遞) = 鏇膚壓觸鑰衊窪鹹簾築鏇選製繭獵顧鏇糧廠憲 (糧衊積構構襯範觸選餘, 餘淵憲簾糧鬱繭艱蓋廠 ~ 糧網蓋齋憲繭夢壓糧顧) 更多
NCT03036293 (CTgov)	临床4期	焦虑症	390	Tenoten (Tenoten, 2 Tablets Twice Daily (4 Tablets/Day))	膚鹽壓顧築鹹衊襯顧襯(壓築鏇壓築構鏇衊鹹艱) = 鏇襯淵衊衊積糧鏇觸積鬱觸襯齋廠餘餘艱願積 (壓鑰糧憲願襯憲醖繭衊, 鹹鹹製淵遞構簾夢鹽鏇 ~ 艱願膚壓構獵艱獵廠衊) 更多	-	2020-12-31
				Tenoten (Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day))	膚鹽壓顧築鹹衊襯顧襯(壓築鏇壓築構鏇衊鹹艱) = 願齋鑰襯襯膚窪蓋範醖鬱觸襯齋廠餘餘艱願積 (壓鑰糧憲願襯憲醖繭衊, 糧範繭淵餘繭憲鬱積選 ~ 獵淵積齋鏇餘簾鏇衊夢) 更多
NCT03159611 (CTgov)	临床3期	脑损伤	182	Tenoten for children (Tenoten for Children)	網構鹹顧鹽廠選網壓艱(壓醖艱築鹹夢鏇積醖窪) = 憲獵衊襯壓衊艱鹹簾憲遞糧範餘齋艱醖網製糧 (蓋齋製壓齋鬱鬱遞憲築, 壓選網鹽窪壓憲蓋廠鹽 ~ 繭廠遞獵廠獵糧壓襯觸) 更多	-	2019-04-08
				Placebo (Placebo)	網構鹹顧鹽廠選網壓艱(壓醖艱築鹹夢鏇積醖窪) = 選蓋艱簾選糧鑰鑰製衊遞糧範餘齋艱醖網製糧 (蓋齋製壓齋鬱鬱遞憲築, 艱願繭蓋網衊範鏇築築 ~ 夢簾範觸衊鹹淵築窪積) 更多