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

• Status: Completed
• Trial end date: 2019-02-18
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of the study:

• To assess efficacy of Tenoten for children® in children with specific developmental disorders of scholastic skills.

• To assess safety of Tenoten for children® in children with specific developmental disorders of scholastic skills.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Materia Medica Holding

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).