PMID- 33081444 OWN - NLM STAT- MEDLINE DCOM- 20201023 LR - 20220531 IS - 1997-7298 (Print) IS - 1997-7298 (Linking) VI - 120 IP - 9 DP - 2020 TI - [Developmental disorders of academic skills in children: the efficacy and safety of Tenoten for children in the multicenter double-blind placebo-controlled randomized study]. PG - 28-36 LID - 10.17116/jnevro202012009128 [doi] AB - 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. FAU - Zavadenko, N N AU - Zavadenko NN AUID- ORCID: 0000-0003-0103-7422 AD - Pirogov Russian National Research Medical University, Moscow, Russia. FAU - Skripchenko, N V AU - Skripchenko NV AUID- ORCID: 0000-0001-8927-3176 AD - Scientific Research Institute of Children's Infections of the Federal Medical and Biological Agency, St. Petersburg, Russia. FAU - Gaynetdinova, D D AU - Gaynetdinova DD AUID- ORCID: 0000-0002-4255-9107 AD - Kazan State Medical University, Kazan, Russia. FAU - Khaletskaya, O V AU - Khaletskaya OV AUID- ORCID: 0000-0002-8531-3174 AD - Privolzhsky Research Medical University, Nizhniy Novgorod, Russia. AD - LLC <>, Nizhniy Novgorod, Russia. FAU - Doronina, O B AU - Doronina OB AUID- ORCID: 0000-0002-5136-7430 AD - Novosibirsk State Medical University, Novosibirsk, Russia. FAU - Suvorinova, N Yu AU - Suvorinova NY AUID- ORCID: 0000-0002-1783-7398 AD - Pirogov Russian National Research Medical University, Moscow, Russia. FAU - Sagautdinova, E Sh AU - Sagautdinova ES AUID- ORCID: 0000-0002-6752-8382 AD - Sverdlovsk Region Children's Clinical Hospital of Rehabilitation The Scientific and Practical Center Bonum, Ekaterinburg, Russia. FAU - Boychevskaya, Yu O AU - Boychevskaya YO AUID- ORCID: 0000-0003-4991-6653 AD - Specialized Clinical Psychiatric Hospital No. 1 of the Ministry of Health of the Krasnodar Region, Krasnodar, Russia. FAU - Panteleeva, M V AU - Panteleeva MV AUID- ORCID: 0000-0002-4099-8202 AD - Moscow Regional Research and Clinical Institute (<>), Moscow, Russia. FAU - Teplyakova, E D AU - Teplyakova ED AUID- ORCID: 0000-0002-3585-7026 AD - <> of Rostov-on-Don, Rostov-on-Don, Russia. FAU - Antonova, T I AU - Antonova TI AUID- ORCID: 0000-0003-4970-0430 AD - St. Petersburg <>, St. Petersburg, Russia. LA - rus PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial TT - Narusheniya razvitiya uchebnykh navykov u detei: effektivnost' i bezopasnost' Tenotena detskogo po dannym mnogotsentrovogo dvoinogo slepogo platsebo-kontroliruemogo randomizirovannogo issledovaniya. PL - Russia (Federation) TA - Zh Nevrol Psikhiatr Im S S Korsakova JT - Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova JID - 9712194 RN - 0 (Antibodies) RN - 0 (tenoten) SB - IM MH - *Antibodies MH - Child MH - Double-Blind Method MH - *Dyslexia/drug therapy MH - Humans MH - Russia OTO - NOTNLM OT - specific developmental disorders of academic skills OT - tenoten for children EDAT- 2020/10/22 06:00 MHDA- 2020/10/24 06:00 CRDT- 2020/10/21 04:53 PHST- 2020/10/21 04:53 [entrez] PHST- 2020/10/22 06:00 [pubmed] PHST- 2020/10/24 06:00 [medline] AID - 10.17116/jnevro202012009128 [doi] PST - ppublish SO - Zh Nevrol Psikhiatr Im S S Korsakova. 2020;120(9):28-36. doi: 10.17116/jnevro202012009128.