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

Zavadenko N.N.

Pirogov Russian National Research Medical University

ORCID: 0000-0003-0103-7422

Skripchenko N.V.

Children’s Research and Clinical Center for Infectious Diseases;
St. Petersburg State Pediatric Medical University

Gaynetdinova D.D.

Kazan State Medical University

Khaletskaya O.V.

Privolzhsky Research Medical University;
LLC «NIJMEDKLINIKA»

Doronina O.B.

Sibneiromed

ORCID: 0000-0002-5136-7430

Suvorinova N.Yu.

Pirogov Russian National Research Medical University

Sagautdinova E.Sh.

Sverdlovsk Region Children’s Clinical Hospital of Rehabilitation The Scientific and Practical Center Bonum

Boychevskaya Yu.O.

Specialized Clinical Psychiatric Hospital No. 1 of the Ministry of Health of the Krasnodar Region

Panteleeva M.V.

Moscow Regional Research and Clinical Institute («MONIKI»)

Teplyakova E.D.

«Children’s city polyclinic No. 4» of Rostov-on-Don

Antonova T.I.

St. Petersburg «Children’s city clinic No. 35»

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

Authors:

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

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Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2020;120(9): 28‑36

DOI: 10.17116/jnevro202012009128

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To cite this article:

Zavadenko NN, Skripchenko NV, Gaynetdinova DD, et al. . Developmental disorders of academic skills in children: the efficacy and safety of Tenoten for children in the multicenter double-blind placebo-controlled randomized study. S.S. Korsakov Journal of Neurology and Psychiatry. 2020;120(9):28‑36. (In Russ.)
https://doi.org/10.17116/jnevro202012009128

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OBJECTIVE

To 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 METHODS

Two 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.

RESULTS

The 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.

CONCLUSIONS

Tenoten 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.

Keywords:

specific developmental disorders of academic skills

tenoten for children

Authors:

Zavadenko N.N.

Pirogov Russian National Research Medical University

ORCID: 0000-0003-0103-7422

Skripchenko N.V.

Children’s Research and Clinical Center for Infectious Diseases;
St. Petersburg State Pediatric Medical University

Gaynetdinova D.D.

Kazan State Medical University

Khaletskaya O.V.

Privolzhsky Research Medical University;
LLC «NIJMEDKLINIKA»

Doronina O.B.

Sibneiromed

ORCID: 0000-0002-5136-7430

Suvorinova N.Yu.

Pirogov Russian National Research Medical University

Sagautdinova E.Sh.

Sverdlovsk Region Children’s Clinical Hospital of Rehabilitation The Scientific and Practical Center Bonum

Boychevskaya Yu.O.

Specialized Clinical Psychiatric Hospital No. 1 of the Ministry of Health of the Krasnodar Region

Panteleeva M.V.

Moscow Regional Research and Clinical Institute («MONIKI»)

Teplyakova E.D.

«Children’s city polyclinic No. 4» of Rostov-on-Don

Antonova T.I.

St. Petersburg «Children’s city clinic No. 35»

Received:

06.07.2020

Accepted:

30.07.2020

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