Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-24 @ 8:00 PM
NCT ID:
NCT03159104
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
9 Years
Study:
NCT03159104
Study Brief:
Protocol Section:
NCT03159104