[Treatment of attention deficit hyperactivity disorder in children: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial]. / Terapiya sindroma defitsita vnimaniya s giperaktivnost'yu u detei: rezul'taty mnogotsentrovogo randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo klinicheskogo issledovaniya.

OBJECTIVE: Evaluation of the efficacy and safety of the new drug Prospekta in the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 7-12 years. MATERIAL AND METHODS: A multicenter (35 clinical centres) double-blind, placebo-controlled, randomized, parallel-group clinical trial enrolled 363 patients. The mean age was 9.3±1.7 years. Children of both sexes aged between 7 and 12 years with a diagnosis of ADHD confirmed by DSM-V diagnostic criteria were included in the study. Patients with a total score of 22 or more on the Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) were included in the study. After randomisation, patients in group 1 received Prospekta, 1 tablet twice daily; patients in group 2 received placebo according to the study drug regimen. The primary efficacy criterion was the proportion of patients with a 25% or greater reduction in the overall ADHD-RS-V scale score after 8 weeks of treatment. As additional criteria for efficacy assessment were assessed: change of ADHD-RS-V total score from baseline after 8 weeks of treatment; Clinical Global Impression Efficacy Index (CGI-EI) score after 8 weeks of treatment; side effects. RESULTS: The proportion of patients with a 25% or more reduction in the ADHD-RS-V scale score after 8 weeks of treatment was 55.9% in the Prospekta group, and 43.3% in the placebo group (p=0.0199). There was a reduction of ADHD symptoms in the Prospekta group as a mean ADHD-RS-V score decreased by 10.2±7.7 (in the placebo group by 8.1±7.9); the difference between the mean ADHD-RS-V score reduction during Prospekta and placebo treatment was 2.09±7.81 (p=0.0096). Mean CGI-EI scores calculated on the basis of physician scores were different in the Prospekta group compared to the placebo group at 6.9±3.2 versus 8.0±3.1 (p=0.0012), indicating greater clinical efficacy of the study drug. The frequency of adverse events (AEs) did not differ significantly between the groups. There were a total of 66 AEs in 46 patients, including 31 AEs in 23 (13.2%) Prospekta group participants and 35 AEs in 23 (12.2%) placebo group participants (p=0.87). No cases of serious AEs were reported during the study. Prospekta is compatible with drugs used in pediatric practice. Prospekta did not cause an exciting effect and did not adversely affect the sleep of patients. CONCLUSION: The drug Prospekta is an effective and safe treatment for ADHD in patients 7-12 years old.

[Results of a multicentre double-blind randomised placebo-controlled clinical trial evaluating the efficacy and safety of Mexidol in the treatment of Attention Deficit Hyperactivity Disorder in Children (MEGA)]. / Rezul'taty mnogotsentrovogo dvoinogo slepogo randomizirovannogo platsebo-kontroliruemogo klinicheskogo issledovaniya po otsenke effektivnosti i bezopasnosti preparata Meksidol v lechenii sindroma defitsita vnimaniya s giperaktivnost'yu u detei (MEGA).

OBJECTIVES: To evaluate the efficacy and safety of two dosing regimens of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT¼ LLC Russia), compared with placebo in children with attention deficit hyperactivity disorder (ADHD) aged 6 to 12 years. MATERIAL AND METHODS: A multicenter randomized, double-blind, placebo-controlled study in 3 parallel groups was conducted in 14 clinical centres of the Russian Federation to assess efficacy and safety of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT¼ LLC Russia) in the treatment of attention deficit hyperactivity disorder (ADHD) in children 6-12 years old with different dosing regimens. The study involved 333 boys and girls aged 6 to 12 years with a confirmed diagnosis of ADHD established in accordance with ICD-10 and DSM-5 criteria. After screening (up to 14 days) the patients were randomised into 3 treatment groups in a 1:1:1: Mexidol 125 mg 2 times daily, Mexidol 125 mg daily+placebo and the placebo group. The duration of treatment in all groups was 42 days. 332 children completed the study. ADHD and comorbid disorders assessment scales were used. RESULTS: There were statistically significant changes in the sum of the total scores on the SNAP-IV inattention and hyperactivity/impulsivity subscales after 6 weeks of therapy in all three study groups (p<0.05). There were statistically significant differences between the Mexidol 125 mg and placebo groups and between the Mexidol 125 mg 2 times daily and placebo groups (for the PP population: p=0.000308 and p=0.000024, respectively; for the FAS population: p=0.000198 and p=0.000024, respectively), indicating that Mexidol therapy is superior to placebo. Statistically significant differences (p<0.05) were also obtained for most of the secondary efficacy criteria (average change in SNAP-IV inattention subscale score, average change in SNAP-IV hyperactivity/impulsivity subscale score, average change in SNAP-IV subscale score - Conners index, average change in ADHD-RS-IV score, change in CGI-ADHD-S scores, change in CGI-I score - the Clinical Global Impressions Scale - Improvement) when comparing Mexidol therapy with placebo. The results of statistical analysis of the incidence of adverse events, laboratory values, physical examination show no significant differences between the compared groups in the main safety parameters. CONCLUSIONS: The regimen of Mexidol, 125 mg film-coated tablets twice daily has been shown to be superior to the regimen of Mexidol, 125 mg film-coated tablets once daily and placebo. The safety profiles of the studied dosing regimens of Mexidol and placebo were comparable.

[Developmental disorders of academic skills in children: the efficacy and safety of Tenoten for children in the multicenter double-blind placebo-controlled randomized study]. / Narusheniya razvitiya uchebnykh navykov u detei: effektivnost' i bezopasnost' Tenotena detskogo po dannym mnogotsentrovogo dvoinogo slepogo platsebo-kontroliruemogo randomizirovannogo issledovaniya.

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.

[Pharmacotherapy of psychomotor developmental delay in 6-12 months preterm infants with hypoxic-ischemic encephalopathy (the double-blind comparative multicenter placebo-controlled study)]. / Farmakoterapiia zaderzhki psikhomotornogo razvitiia u detei 6-12 mes, rozhdennykh nedonoshennymi i perenesshikh gipoksicheski-ishemicheskoe porazhenie golovnogo mozga (dvoinoe slepoe sravnitel'noe mnogotsentrovoe platsebo-kontroliruemoe issledovanie).

AIM: To evaluate the efficacy and safety of hopantenic acid (Pantogam) in the complex treatment of prematurely born infants, aged 6-12 months, with psychomotor developmental delay due to hypoxic-ischemic encephalopathy. MATERIAL AND METHODS: Eighty-seven patients were randomized into two groups: 44 received standardized treatment and pantogam for two months, 43 standardized treatment and placebo. Pantogam (syrup 100 mg/ml) or placebo were prescribed orally 15-30 minutes after feeding, twice a day, in a daily dosage of 30-50 mg/kg body weight. The assessment of psychomotor development from birth to two years was performed with the Griffiths Mental Development Scales (GMDS-ER) twice (before and after completion of therapy). RESULTS: The response to two month therapy determined as the reduction of developmental delay for more than 6% of the initial GMDS-ER general quotient (GQ) score was significantly better in the group I after pantogam treatment (63.6% of patients) compared to group II (36.4%, p=0.021). Group I demonstrated the significant decrease of the developmental delay in two domains ('Personal-Social' and 'Performance') and a trend to overcome the delay in three other domains: 'Locomotor', 'Hearing and Speech', 'Eye and Hand Coordination'. The improvement after pantogam treatment was more obvious in the subgroup of infants born late preterm (gestational age 34-36 weeks) compared to infants born moderate preterm (gestational age 32-33 weeks). The favorable safety profile of pantogam was confirmed, comparable to that of placebo. CONCLUSION: Pantogam is efficient and safe medication in the complex treatment of psychomotor developmental delay in preterm infants, aged 6-12 months.

[Therapy of perinatal brain injury outcomes: results of a multicenter double-blind placebo-controlled randomized study of tenoten for children (liquid dosage form)]. / Terapiya posledstvii perinatal'nogo porazheniya tsentral'noi nervnoi sistemy: rezul'taty mnogotsentrovogo dvoinogo slepogo platsebo-kontroliruemogo randomizirovannogo klinicheskogo issledovaniya zhidkoi lekarstvennoi formy preparata Tenoten detskii.

OBJECTIVE: To evaluate the efficacy and safety of tenoten for children (a novel liquid pediatric formulation) in the treatment of perinatal brain injury (PBI) outcomes. MATERIAL AND METHODS: The multicenter double-blind placebo-controlled randomized trial enrolled 184 children (aged 29 days-9 months) with the total score 12-27 according to Djurba-Mastukova scale and the level of physical development 25-75 centiles. Patients were randomized into tenoten (10 drops per day) and placebo groups. Treatment period was 12 weeks ± 5 days. Percentage of patients with ≥4 points improvement according to Djurba-Mastukova scale (responder rate) was used as a primary efficacy endpoint. RESULTS AND CONCLUSION: Patients in the tenoten group had a significant result on primary efficacy endpoint: 77.5% of participants responded to therapy (p=0.02 vs. placebo). In addition, the safety of tenoten for children in the treatment of PBI outcomes is shown. Tenoten for children (a novel liquid pediatric formulation) has been shown to be an effective medication in treatment of PBI outcomes that helps to achieve therapeutic results with minimal side-effects, good tolerability and the high level of adherence to therapy.

[Clinical and Doppler ultrasound study of women with cephalalgia and antiphospholipid syndrome]. / Klinicheskoe i dopplerograficheskoe obsledovanie zhenshchin s tsefalgiei i antifosfolipidnym sindromom.

AIM: To study clinical characteristics and Doppler and laboratory parameters in women with headache and antiphospholipid syndrome. MATERIAL AND METHODS: One hundred and forty-three women with headache (34 with migraine, 53 with tension type headache) and antiphospholipid syndrome and 56 healthy controls were examined. RESULTS: Coagulogram and cerebral blood flow parameters were significantly different between controls and patients with headache and antiphoshpolipid syndrome. All women with antiphoshpolipid syndrome had changes in the thrombotic system and plasma. Blood flow parameters were higher in all patients with headache and antiphoshpolipid syndrome. CONCLUSION: Changes in laboratory and Doppler parameters depend on the clinical manifestations of cephalalgia, as well as the age of patients.

[The influence of anticoagulant and antiagregant therapy during pregnancy on clinical characteristics and outcomes of periventricular hemorrhages in newborns]. / Vliianie gravidarnoi antiagregantnoi terapii na kliniku i iskhody periventrikuliarnykh krovoizliianii u novorozhdennykh.

AIM: To evaluate the characteristics of periventricular hemorrhages (PVH) in newborns of mothers receiving antiplatelet and anticoagulation therapy during pregnancy with hypercoagulation syndrome. MATERIAL AND METHODS: One hundred and twelve newborns with PVH were evaluated: group 1 - 37 children, born after a pregnancy with hypercoagulation syndrome and antithrombotic therapy; group 2 - 55 children, born after a pregnancy without hypercoagulation syndrome and with preventive antithrombotic therapy; group 3 - 20 children, born after a pregnancy without hypercoagulation syndrome and without antithrombotic therapy. All newborns underwent clinical and neurologic examinations combined with assessment using special scales and intracranial ultrasound evaluation. RESULTS AND CONCLUSION: Maternal anticoagulation therapy during pregnancy in groups I and 2 was associated with more severe condition of newborns with PVH (significantly prolonged artificial lung ventilation, more premature births, larger hemorrhage) compared to newborns in group 3. Follow-up of infants in groups I and 2 demonstrated a significantly slower progress of postural muscle tone, psychological and psychomotor development compared to infants in group 3. Hypercoagulation syndrome treatment during pregnancy significantly affects the severity of newborn's condition at birth and the development of severe neurological impairments in long-term period.