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
Intervention: Tenoten for children; Placebo
Intervention description: Tablet for oral use.; Tablet for oral use.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 7 Years
Maximum age: 9 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children of either gender aged 7 to 9 years old.

          2. School children of grades 1-3 (grade 1 children will be enrolled at the beginning of
             the second half of the year) in regular schools with state accreditation with
             principal educational program of elementary general education in compliance with
             Federal State Educational Standard of the Russian Federation.

          3. Beginning of the second half of the year (only for 1st grades).

          4. Specific developmental disorder of scholastic skills such as:

               -  specific reading disorder (F81.0);

               -  specific spelling disorder (F81.1);

               -  specific disorder of arithmetical skills (F81.2);

               -  mixed disorder of scholastic skills (F81.3; i.e. meeting the criteria for one of
                  the following combinations: F81.2+F81.0, F81.2+F81.1, or F81.2+F81.0+F81.1).

          5. Reading score of 15 to 35 on the Reading Skills test (L.A. Fotekova, T.V. Akhutina,
             2002).

          6. Spelling score of 15 to 30 on the Spelling Skills test (L.A. Fotekova, T.V. Akhutina,
             2002).

          7. Counting score of 5 to 15 on subtest No. 3 "Arithmetic" (of Wechsler Intelligence
             Scale for Children).

          8. Availability of a patient information sheet (Informed Consent form) signed by the
             parent/adopter to confirm the child's participation in the clinical trial.

        Exclusion Criteria:

          1. History of the diseases:

               -  Diseases of the nervous system, including

                    -  inflammatory diseases of the central nervous system;

                    -  systemic atrophies;

                    -  extrapyramidal and movement disorders;

                    -  degenerative diseases of the nervous system;

                    -  demyelinating diseases of the central nervous system;

                    -  episodic and paroxysmal disorders;

                    -  polyneuropathies;

                    -  diseases of myoneural junction and muscle;

                    -  cerebral palsy.

               -  Congenital malformations of the nervous system (excl. Spina bifida without
                  hydrocephalus)

               -  Diseases and congenital malformations of the eye causing impairment of vision.

               -  Diseases and congenital malformations of the ear causing impairment of hearing.

               -  Organic mental disorders.

               -  Mental retardation ranging from mild to profound.

               -  Stuttering (stammering).

               -  Obsessive-compulsive disorder.

               -  Pervasive developmental disorders including:

                    -  childhood autism;

                    -  atypical autism;

                    -  Rett syndrome;

                    -  overactive disorder associated with mental retardation and stereotyped
                       movements;

                    -  Asperger syndrome.

               -  Phakomatoses (tuberous sclerosis, neurofibromatosis).

               -  Postconcussional syndrome.

               -  Hereditary metabolic diseases, including glycogen storage disease (glycogenosis),
                  disorders of galactose metabolism (galactosemia), other disorders of carbohydrate
                  metabolism, disorders of glycosaminoglycan metabolism (mucopolysaccharidoses),
                  disorders of aromatic amino-acid metabolism (phenylketonuria, tyrosinemia, etc.),
                  disorders of branched-chain amino-acid metabolism and fatty-acid metabolism
                  (maple-syrup-urine disease), mitochondrial myopathy.

               -  Chromosomal abnormalities.

          2. Administration of the products specified in section "Forbidden concomitant therapy"
             within the previous 4 weeks.

          3. Necessity in pharmacotherapy for underlying and/or concomitant disease during the
             following 12 weeks.

          4. Acute infectious disease or exacerbation/decompensation of a disease affecting the
             patient's ability to participate in the trial.

          5. Malignant neoplasm/suspected malignant neoplasm.

          6. Allergy/intolerance to any of the components of medications used in the treatment.

          7. Malabsorption syndrome including congenital or acquired lactase deficiency (or another
             disaccharidase deficiency), and galactosemia.

          8. Mental disorders of patient's parent(s)/adopter(s).

          9. Use of drugs or alcohol by the patient's parents/adopters at > 2 alcohol units a day
             (1 unit of alcohol is equivalent to 0.33 L of lager/150 mL of unfortified wine, or 40
             mL of Ethyl Alcohol).

         10. Participation in other clinical trials in the previous 3 months.

         11. Patients whose parent(s)/adopter(s), from the investigator's point of view, will fail
             to comply with the observation requirements of the trial or with the dose regimen of
             the investigational drug.

         12. Patients whose parent(s)/adopter(s) are related to any of the on-site research
             personnel directly involved in the conduct of the trial or are an immediate relative
             of the study investigator. "Immediate relative" means husband, wife, parent, son,
             daughter, brother, or sister (regardless of whether they are natural or adopted).

         13. Patients whose parent(s)/adopter(s) work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e.,
             is the company's employee, temporary contract worker, or, designated officials
             responsible for carrying out the research or any immediate relatives of the
             aforementioned).