Specific Developmental Disorders of Scholastic Skills Clinical Trial
Official title:
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.
A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of the study treatment. The study will enroll the school children (boys and girls) of grades 1, 2 and 3 of a regular school aged 7-9 years old (grade 1 school children will be enrolled at the beginning of the second half of the year) complaining of difficult learning classified according to ICD-10 as specific developmental disorders of scholastic skills (F81) including: - specific reading disorder (F81.0); - specific spelling disorder (F81.1); - specific disorder of arithmetical skills (F81.2); - mixed disorder of scholastic skills (F81.3); - disorder simultaneously meeting criteria of F81.2+F81.0 or F81.2+F81.1, or F81.2+F81.0+F81.1. The developmental disorders of scholastic skills will be verified by a doctor (either a neurologist or psychiatrist) according to reading, spelling, and counting tests. The children may have any concomitant diseases not considered as exclusion criteria and not requiring therapy during the following 12 weeks using the products specified in section "Forbidden concomitant therapy". Specific additional educational programs should not be performed within 12 weeks after enrollment either. On signing information sheet (informed consent form) by the parent/adopter the patients will be examined by a neurologist or psychiatrist and tested for reading skills (method by L.A. Fotekova, Т.V. Akhutina, 2002;), spelling skills (method by L.A. Fotekova, Т.V. Akhutina, 2002) and counting skills (subtest No. 3 "Arithmetic" WISC test), and concomitant therapy will be recorded. If inclusion criteria are met and non-inclusion criteria are absent at Visit 1, the patient will be enrolled in the trial and randomized into one of the two groups: 1 tablet of Tenoten for children three times daily for 3 months (group 1) or the same dosing regimen of Placebo (group 2). At Visit 1 the parents/adopters will receive the study product for 12-week treatment period and a diary to report any potential adverse events and cases of concomitant therapy. Six weeks later (Week 6±3 days) a "Phone visit" (Visit 2) will be made in order to interview parents about the patient's condition, the presence/absence of concomitant diseases, adverse events. At Visit 3 (Week 12±3 days) repeated testing of reading, spelling and counting skills will be made, complaints, data on concomitant diseases, concomitant therapy, and adverse events will be collected. The investigator will evaluate the subject's compliance and fill in the Clinical Global Impression Scale to calculate Efficacy Index (CGI-EI). The patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Forbidden concomitant therapy". ;