Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children

Inclusion Criteria

• Children of either gender aged 7 to 9 years old.
• 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.
• Beginning of the second half of the year (only for 1st grades).
• 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).
• Reading score of 15 to 35 on the Reading Skills test (L.A. Fotekova, T.V. Akhutina, 2002).
• Spelling score of 15 to 30 on the Spelling Skills test (L.A. Fotekova, T.V. Akhutina, 2002).
• Counting score of 5 to 15 on subtest No. 3 "Arithmetic" (of Wechsler Intelligence Scale for Children).
• 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

• 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.
• Administration of the products specified in section "Forbidden concomitant therapy" within the previous 4 weeks.
• Necessity in pharmacotherapy for underlying and/or concomitant disease during the following 12 weeks.
• Acute infectious disease or exacerbation/decompensation of a disease affecting the patient's ability to participate in the trial.
• Malignant neoplasm/suspected malignant neoplasm.
• Allergy/intolerance to any of the components of medications used in the treatment.
• Malabsorption syndrome including congenital or acquired lactase deficiency (or another disaccharidase deficiency), and galactosemia.
• Mental disorders of patient's parent(s)/adopter(s).
• 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).
• Participation in other clinical trials in the previous 3 months.
• 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 inve