Trial Outcomes & Findings for Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children (NCT NCT03159104)

Race and Ethnicity were not collected from any participant.

The total scholastic skill score is calculated based on the points for reading, spelling, and counting skills. Reading skills are estimated according to scale consisting of three subscales:reading speed, reading method/understanding, and reading accuracy. The minimum value of reading skills scale is 0 points, and the maximum value is 45 points. Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. The minimum value is 0 points, and the maximum value is 45 points. Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. The minimum value is 0 points, and the maximum value is 20 points. Total scholastic skill score is a sum of three scales (reading, spelling, and counting). The minimum value is 0 points, and the maximum value is 110 points. A higher score means the best results.

Reading skills are estimated according to scale consisting of three subscales: reading speed, reading method/understanding, and reading accuracy. Students of 7 years old are invited to read the words, and students of 8-9 years old are invited to read a small text. Speed, method, and accuracy of the reading are estimated in students of 7 years old. Speed, accuracy, and understanding of the text are estimated in students of 8-9 years old. The minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.

Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. Students of 7 years old are invited to write dictated letters, their names, and three words (mom, table, trunk), and students of 8-9 years old are invited to write a small dictation. Dysgraphic errors and their types as well as the number of non-dysgraphic errors are taken into consideration for estimation. The minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.

Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. "Arithmetic" subtest includes 16 tasks from elementary school arithmetic which are tackled verbally. Easiness of operating numbers, accuracy, and time spent on the tasks are estimated. Each task is rated in points (0 or 1), by the end of testing and rating for each task the sum of points (raw score) is calculated and converted into a scale score using standard tables. The minimum value is 0 points, and the maximum value is 20 points. A higher score meant the best results.

Percentage of children with an increase in total scholastic skills score (a sum of three scales: reading, spelling, and counting). Total scholastic skill score is a sum of three scales (reading, spelling, and counting). The minimum value is 0 points, and the maximum value is 110 points. A higher score meant the best results. The increase in total scholastic skills score means an increasing by at least 5 points compared to baseline.

The Clinical Global Impression-Efficiency Index (CGI-E) scale consists of two subscales. Efficacy subscale measures efficacy of medicine based on the severity of symptoms at the end of therapy. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results. Side effects subscale measures side effects of the medicine. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results. The scale is filled in by the doctor at the final visit after 12 weeks of the treatment. In accordance with the results of treatment, the doctor expresses his opinion about the efficacy of the therapy and the degree of medicine safety, making marks in the appropriate columns of the table. The efficacy index is determined as intersection of columns of indicators of efficacy and side effects in the table. The minimum value is 0.25 points, and the maximum value is 4 points. A higher score means the best results.