Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children
Condition: Specific Developmental Disorders of Scholastic Skills
MeSH terms: Learning Disabilities; Developmental Disabilities
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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".
    

Intervention name(s): Tenoten for children; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral use.; Tablet for oral use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment