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

NCT03159104 | Completed Phase 3 Results

• 1 other identifier: MMH-TD-005
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Specific Developmental Disorders of Scholastic Skills

Outcome Measures

Primary Outcomes (1)

• Mean Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).

  The total scholastic skill score is calculated based on the points for reading, spelling, and counting skills. Reading skills are estimated according to scale consisting of three subscales:reading speed, reading method/understanding, and reading accuracy. The minimum value of reading skills scale is 0 points, and the maximum value is 45 points. Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. The minimum value is 0 points, and the maximum value is 45 points. Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. The minimum value is 0 points, and the maximum value is 20 points. Total scholastic skill score is a sum of three scales (reading, spelling, and counting). The minimum value is 0 points, and the maximum value is 110 points. A higher score means the best results.

  On Day 1 and after 12 weeks of the therapy

Secondary Outcomes (5)

• Mean Reading Skills Score

  On Day 1 and after 12 weeks of the therapy

• Mean Score Spelling Skills Score

  On Day 1 and after 12 weeks of the therapy

• Mean Counting Skills Score.

  On Day 1 and after 12 weeks of the therapy

• Percentage of Children With an Increase in Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).

  On Day 1 and after 12 weeks of the therapy

• Efficacy Index According to Clinical Global Impression Scale.

  In 12 weeks of the treatment.

Study Arms (2)

Tenoten for children

EXPERIMENTAL

Dose per administration: 1 tablet. 1 tablet three times daily (3 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.

Drug: Tenoten for children

Placebo

PLACEBO COMPARATOR

Dose per administration: 1 tablet. 1 tablet three times daily (3 tablets per day). The tablets should be held in the mouth until complete dissolution, without meal.

Drug: Placebo

Interventions

Tenoten for children DRUG

Tablet for oral use.

Tenoten for children

Placebo DRUG

Tablet for oral use.

Placebo

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (10)

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation

Kazan', 420012, Russia

Location

The State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital No. 1" of the Krasnodar Region Health Department

Krasnodar, 350007, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation

Moscow, 117997, Russia

Location

Moscow Regional Research and Clinical Institute ("MONIKI")

Moscow, 129110, Russia

Location

Limited Liability Company "NIZHMEDCLINIKA"

Nizhny Novgorod, 603159, Russia

Location

LLC City Neurological Center "Sibneyromed"

Novosibirsk, 630064, Russia

Location

Municipal budgetary health care institution "Children's City Polyclinic № 4 of Rostov-on-Don"

Rostov-on-Don, 344065, Russia

Location

St. Petersburg State Budgetary Institution of Health "Children's City Polyclinic № 35"

Saint Petersburg, 196191, Russia

Location

Pediatric Research and Clinical Center for Infectious Diseases

Saint Petersburg, 197022, Russia

Location

State Budgetary Healthcare Institution of Sverdlovsk Region Children's Clinical Hospital of Rehabilitation The Scientific and Practical Center "Bonum"

Yekaterinburg, 620149, Russia

Location

MeSH Terms

Interventions

tenoten

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 18, 2017
• Study Start: August 25, 2015
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2021-10

Locations

RU (10)