Clinical trial: Clinical Trial of Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children (NCT03159104)

Eligibility criteria:
Inclusion Criteria:

          1. Children of both sexes aged from 7 to 9 years.

          2. First to third grade students (1st-graders will be enrolled at the beginning of the
             second academic semester) at state-accredited secondary schools following the general
             elementary education program in compliance with Russia's National Federal Educational
             Standard.

          3. Beginning of the second academic semester (only for 1st-graders).

          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. Writing score of 15 to 30 on the Writing Skills test (L.A. Fotekova, T.V. Akhutina,
             2002).

          7. Counting score of 5 to 15 on the WISC (subtest III - Arithmetic).

          8. Availability of a patient information sheet (Informed Consent form) signed by the
             patient's parent(s)/adopter(s) to confirm the child's participation in the clinical
             trial signed by one parent/adopter of patient.

        Exclusion Criteria:

          1. Prior medical diagnoses:

               -  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 eye causing impairment of vision.

               -  Diseases and congenital malformations of 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 (glycogenoses),
                  disorders of galactose metabolism (galactosaemia), other disorders of
                  carbohydrate metabolism, disorders of glycosaminoglycan metabolism
                  (mucopolysaccharidoses), disorders of aromatic amino-acid metabolism
                  (phenylketonuria, tyrosinaemia etc.), disorders of branched-chain amino-acid
                  metabolism and fatty-acid metabolism (maple-syrup-urine disease), mitochondrial
                  myopathy.

               -  Chromosomal abnormalities.

          2. Intake of medicines listed in the section 'Prohibited concomitant treatment' for 4
             weeks prior to the enrollment in the trial.

          3. Need to administer drugs for the underlying disease and/or comorbid condition in the
             following 12 weeks.

          4. Acute infectious disease or exacerbation/decompensation of a disease affecting
             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), galactosemia.

          8. Mental disorders of patient's parent(s)/adopter(s).

          9. Drug addiction, alcohol use in the amount over 2 units of alcohol a day by the
             patient's parent(s)/adopter(s).

         10. Participation in other clinical studies within 3 months prior to inclusion in this
             trial.

         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/adopter is related to the clinical site's research staff
             directly involved in the trial, or is the immediate family member of the researcher.
             The immediate family members include husband/wife, parents, children or brothers (or
             sisters), 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 appointed official responsible
             for carrying out the research or their immediate family).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 9 Years

Patient description (medical language): A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination.  The boy is going to a school for students with learning disabilities.  The patient was adopted, and his immunizations are up to date.  Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value      Normal Range     Patient Value
Glucose                    90-120 mg/dl     95 mg/dl
BUN (Blood Urea Nitrogen)  7-24 mg/dl       10 mg/dl
Creatinine                 0.7-1.4 mg/dl    0.8 mg/dl
Calcium                    8.5-10.5 mg/dl   9 mg/dl
Sodium                     134-143 mEq/L    135 mEq/L
Potassium                  3.5-4.5 mEq/L    3.7 mEq/L
Chloride                   95-108 mEq/L     98 mEq/L
CO2                        20-30 mEq/L      25 mEq/L
Blood pH                   7.38-7.42        7. 39

Patient description (patient's own words): My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range.

Does the patient match the trial criteria? 0