Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-24 @ 7:58 AM
Study NCT ID:
NCT03159104
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C529609', 'term': 'tenoten'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PutilovskiyMA@materiamedica.ru', 'phone': '+74952761571', 'title': 'Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director', 'phoneExt': '302', 'organization': 'MATERIA MEDICA HOLDING'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the treatment period - 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 42, 'seriousNumAtRisk': 122, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 29, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Functional indigestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Food intoxication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pseudoallergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes labial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ARI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ARVI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperexcitability syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Obsessions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Simple vocal tics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchial asthma', 'notes': 'Exacerbation of bronchial asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nose bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasomotor rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Allergic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pitiriasis pink', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Phlegmonous appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.39', 'spread': '12.04', 'groupId': 'OG000'}, {'value': '60.46', 'spread': '11.04', 'groupId': 'OG001'}]}]}, {'title': 'After 12 weeks', 'categories': [{'measurements': [{'value': '79.94', 'spread': '18.22', 'groupId': 'OG000'}, {'value': '74.56', 'spread': '18.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '1', 'ciUpperLimit': '9', 'estimateComment': 'Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.', 'groupDescription': 'The difference between final and initial total scholastic skill score was calculated for each participant. Wilcoxon test was used for comparison of these differences because data distribution differs from normal.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'The total scholastic skill score is calculated based on the points for reading, spelling, and counting skills.\n\nReading 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.\n\nSpelling 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.\n\nCounting 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.\n\nTotal 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Reading Skills Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27.69', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '27.76', 'spread': '6.16', 'groupId': 'OG001'}]}]}, {'title': 'After 12 weeks', 'categories': [{'measurements': [{'value': '34.96', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '33.66', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0608', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '5', 'estimateComment': 'Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Reading skills are estimated according to scale consisting of three subscales: reading speed, reading method/understanding, and reading accuracy.\n\nStudents of 7 years old are invited to read the words, and students of 8-9 years old are invited to read a small text. Speed, method, and accuracy of the reading are estimated in students of 7 years old. Speed, accuracy, and understanding of the text are estimated in students of 8-9 years old.\n\nThe minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Score Spelling Skills Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.56', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '21.59', 'spread': '7.48', 'groupId': 'OG001'}]}]}, {'title': 'After 12 weeks', 'categories': [{'measurements': [{'value': '32.73', 'spread': '13.69', 'groupId': 'OG000'}, {'value': '29.09', 'spread': '14.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0824', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'estimateComment': 'Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. Students of 7 years old are invited to write dictated letters, their names, and three words (mom, table, trunk), and students of 8-9 years old are invited to write a small dictation.\n\nDysgraphic errors and their types as well as the number of non-dysgraphic errors are taken into consideration for estimation.\n\nThe minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Counting Skills Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.14', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '11.10', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'After 12 weeks', 'categories': [{'measurements': [{'value': '12.26', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '11.80', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2391', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '1', 'estimateComment': 'Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. "Arithmetic" subtest includes 16 tasks from elementary school arithmetic which are tackled verbally. Easiness of operating numbers, accuracy, and time spent on the tasks are estimated. Each task is rated in points (0 or 1), by the end of testing and rating for each task the sum of points (raw score) is calculated and converted into a scale score using standard tables.\n\nThe minimum value is 0 points, and the maximum value is 20 points. A higher score meant the best results.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Children With an Increase in Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0033', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Percentage of children with an increase in total scholastic skills score (a sum of three scales: reading, spelling, and counting).\n\nTotal scholastic skill score is a sum of three scales (reading, spelling, and counting).\n\nThe minimum value is 0 points, and the maximum value is 110 points. A higher score meant the best results. The increase in total scholastic skills score means an increasing by at least 5 points compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efficacy Index According to Clinical Global Impression Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'In 12 weeks of the treatment.', 'description': 'The Clinical Global Impression-Efficiency Index (CGI-E) scale consists of two subscales.\n\nEfficacy subscale measures efficacy of medicine based on the severity of symptoms at the end of therapy. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results.\n\nSide effects subscale measures side effects of the medicine. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results.\n\nThe scale is filled in by the doctor at the final visit after 12 weeks of the treatment. In accordance with the results of treatment, the doctor expresses his opinion about the efficacy of the therapy and the degree of medicine safety, making marks in the appropriate columns of the table. The efficacy index is determined as intersection of columns of indicators of efficacy and side effects in the table. The minimum value is 0.25 points, and the maximum value is 4 points. A higher score means the best results.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients who have data on the CGI-EI scale is indicated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'FG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Violation of inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenoten for Children', 'description': '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.\n\nTenoten for children: Tablet for oral use.'}, {'id': 'BG001', 'title': 'Placebo', 'description': '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.\n\nPlacebo: Tablet for oral use.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '8.6', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-01-22', 'size': 313991, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-30T08:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-25', 'studyFirstSubmitDate': '2017-05-17', 'resultsFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-25', 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'The total scholastic skill score is calculated based on the points for reading, spelling, and counting skills.\n\nReading 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.\n\nSpelling 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.\n\nCounting 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.\n\nTotal 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.'}], 'secondaryOutcomes': [{'measure': 'Mean Reading Skills Score', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Reading skills are estimated according to scale consisting of three subscales: reading speed, reading method/understanding, and reading accuracy.\n\nStudents of 7 years old are invited to read the words, and students of 8-9 years old are invited to read a small text. Speed, method, and accuracy of the reading are estimated in students of 7 years old. Speed, accuracy, and understanding of the text are estimated in students of 8-9 years old.\n\nThe minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.'}, {'measure': 'Mean Score Spelling Skills Score', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Spelling skills are estimated according to scale in 0, 15, 30, and 45 points. Students of 7 years old are invited to write dictated letters, their names, and three words (mom, table, trunk), and students of 8-9 years old are invited to write a small dictation.\n\nDysgraphic errors and their types as well as the number of non-dysgraphic errors are taken into consideration for estimation.\n\nThe minimum value is 0 points, and the maximum value is 45 points. A higher score meant the best results.'}, {'measure': 'Mean Counting Skills Score.', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Counting skills are estimated according to subtest No. 3 "Arithmetic" of "Wechsler Intelligence Scale for Children" (WISC) in points. "Arithmetic" subtest includes 16 tasks from elementary school arithmetic which are tackled verbally. Easiness of operating numbers, accuracy, and time spent on the tasks are estimated. Each task is rated in points (0 or 1), by the end of testing and rating for each task the sum of points (raw score) is calculated and converted into a scale score using standard tables.\n\nThe minimum value is 0 points, and the maximum value is 20 points. A higher score meant the best results.'}, {'measure': 'Percentage of Children With an Increase in Total Scholastic Skills Score (a Sum of Three Scales: Reading, Spelling, and Counting).', 'timeFrame': 'On Day 1 and after 12 weeks of the therapy', 'description': 'Percentage of children with an increase in total scholastic skills score (a sum of three scales: reading, spelling, and counting).\n\nTotal scholastic skill score is a sum of three scales (reading, spelling, and counting).\n\nThe minimum value is 0 points, and the maximum value is 110 points. A higher score meant the best results. The increase in total scholastic skills score means an increasing by at least 5 points compared to baseline.'}, {'measure': 'Efficacy Index According to Clinical Global Impression Scale.', 'timeFrame': 'In 12 weeks of the treatment.', 'description': 'The Clinical Global Impression-Efficiency Index (CGI-E) scale consists of two subscales.\n\nEfficacy subscale measures efficacy of medicine based on the severity of symptoms at the end of therapy. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results.\n\nSide effects subscale measures side effects of the medicine. The minimum value is 1 points, and the maximum value is 4 points. A higher score means the best results.\n\nThe scale is filled in by the doctor at the final visit after 12 weeks of the treatment. In accordance with the results of treatment, the doctor expresses his opinion about the efficacy of the therapy and the degree of medicine safety, making marks in the appropriate columns of the table. The efficacy index is determined as intersection of columns of indicators of efficacy and side effects in the table. The minimum value is 0.25 points, and the maximum value is 4 points. A higher score means the best results.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Specific Developmental Disorders of Scholastic Skills']}, 'descriptionModule': {'briefSummary': 'Purpose of the study:\n\n• To evaluate efficacy and safety of Tenoten for children in the treatment of specific developmental disorders of scholastic skills in children.', 'detailedDescription': 'A multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of the study treatment.\n\nThe study will enroll the school children (boys and girls) of grades 1, 2 and 3 of a regular school aged 7-9 years old (grade 1 school children will be enrolled at the beginning of the second half of the year) complaining of difficult learning classified according to ICD-10 as specific developmental disorders of scholastic skills (F81) including:\n\n* specific reading disorder (F81.0);\n* specific spelling disorder (F81.1);\n* specific disorder of arithmetical skills (F81.2);\n* mixed disorder of scholastic skills (F81.3);\n* disorder simultaneously meeting criteria of F81.2+F81.0 or F81.2+F81.1, or F81.2+F81.0+F81.1.\n\nThe developmental disorders of scholastic skills will be verified by a doctor (either a neurologist or psychiatrist) according to reading, spelling, and counting tests. The children may have any concomitant diseases not considered as exclusion criteria and not requiring therapy during the following 12 weeks using the products specified in section "Forbidden concomitant therapy". Specific additional educational programs should not be performed within 12 weeks after enrollment either.\n\nOn signing information sheet (informed consent form) by the parent/adopter the patients will be examined by a neurologist or psychiatrist and tested for reading skills (method by L.A. Fotekova, Т.V. Akhutina, 2002;), spelling skills (method by L.A. Fotekova, Т.V. Akhutina, 2002) and counting skills (subtest No. 3 "Arithmetic" WISC test), and concomitant therapy will be recorded.\n\nIf inclusion criteria are met and non-inclusion criteria are absent at Visit 1, the patient will be enrolled in the trial and randomized into one of the two groups: 1 tablet of Tenoten for children three times daily for 3 months (group 1) or the same dosing regimen of Placebo (group 2).\n\nAt Visit 1 the parents/adopters will receive the study product for 12-week treatment period and a diary to report any potential adverse events and cases of concomitant therapy.\n\nSix weeks later (Week 6±3 days) a "Phone visit" (Visit 2) will be made in order to interview parents about the patient\'s condition, the presence/absence of concomitant diseases, adverse events.\n\nAt Visit 3 (Week 12±3 days) repeated testing of reading, spelling and counting skills will be made, complaints, data on concomitant diseases, concomitant therapy, and adverse events will be collected. The investigator will evaluate the subject\'s compliance and fill in the Clinical Global Impression Scale to calculate Efficacy Index (CGI-EI).\n\nThe patients will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Forbidden concomitant therapy".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children of either gender aged 7 to 9 years old.\n2. 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.\n3. Beginning of the second half of the year (only for 1st grades).\n4. Specific developmental disorder of scholastic skills such as:\n\n * specific reading disorder (F81.0);\n * specific spelling disorder (F81.1);\n * specific disorder of arithmetical skills (F81.2);\n * 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).\n5. Reading score of 15 to 35 on the Reading Skills test (L.A. Fotekova, T.V. Akhutina, 2002).\n6. Spelling score of 15 to 30 on the Spelling Skills test (L.A. Fotekova, T.V. Akhutina, 2002).\n7. Counting score of 5 to 15 on subtest No. 3 "Arithmetic" (of Wechsler Intelligence Scale for Children).\n8. Availability of a patient information sheet (Informed Consent form) signed by the parent/adopter to confirm the child\'s participation in the clinical trial.\n\nExclusion Criteria:\n\n1. History of the diseases:\n\n * Diseases of the nervous system, including\n\n * inflammatory diseases of the central nervous system;\n * systemic atrophies;\n * extrapyramidal and movement disorders;\n * degenerative diseases of the nervous system;\n * demyelinating diseases of the central nervous system;\n * episodic and paroxysmal disorders;\n * polyneuropathies;\n * diseases of myoneural junction and muscle;\n * cerebral palsy.\n * Congenital malformations of the nervous system (excl. Spina bifida without hydrocephalus)\n * Diseases and congenital malformations of the eye causing impairment of vision.\n * Diseases and congenital malformations of the ear causing impairment of hearing.\n * Organic mental disorders.\n * Mental retardation ranging from mild to profound.\n * Stuttering (stammering).\n * Obsessive-compulsive disorder.\n * Pervasive developmental disorders including:\n\n * childhood autism;\n * atypical autism;\n * Rett syndrome;\n * overactive disorder associated with mental retardation and stereotyped movements;\n * Asperger syndrome.\n * Phakomatoses (tuberous sclerosis, neurofibromatosis).\n * Postconcussional syndrome.\n * 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.\n * Chromosomal abnormalities.\n2. Administration of the products specified in section "Forbidden concomitant therapy" within the previous 4 weeks.\n3. Necessity in pharmacotherapy for underlying and/or concomitant disease during the following 12 weeks.\n4. Acute infectious disease or exacerbation/decompensation of a disease affecting the patient\'s ability to participate in the trial.\n5. Malignant neoplasm/suspected malignant neoplasm.\n6. Allergy/intolerance to any of the components of medications used in the treatment.\n7. Malabsorption syndrome including congenital or acquired lactase deficiency (or another disaccharidase deficiency), and galactosemia.\n8. Mental disorders of patient\'s parent(s)/adopter(s).\n9. 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).\n10. Participation in other clinical trials in the previous 3 months.\n11. 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.\n12. 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).\n13. 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).'}, 'identificationModule': {'nctId': 'NCT03159104', 'briefTitle': 'Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Materia Medica Holding'}, 'officialTitle': 'Multicenter Double-blind Placebo-Controlled Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children', 'orgStudyIdInfo': {'id': 'MMH-TD-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenoten for children', 'description': '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.', 'interventionNames': ['Drug: Tenoten for children']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tenoten for children', 'type': 'DRUG', 'description': 'Tablet for oral use.', 'armGroupLabels': ['Tenoten for children']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet for oral use.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '350007', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'The State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital No. 1" of the Krasnodar Region Health Department', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '117997', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Regional Research and Clinical Institute ("MONIKI")', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603159', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Limited Liability Company "NIZHMEDCLINIKA"', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630064', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'LLC City Neurological Center "Sibneyromed"', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '344065', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Municipal budgetary health care institution "Children\'s City Polyclinic № 4 of Rostov-on-Don"', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '196191', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State Budgetary Institution of Health "Children\'s City Polyclinic № 35"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Pediatric Research and Clinical Center for Infectious Diseases', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '620149', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution of Sverdlovsk Region Children\'s Clinical Hospital of Rehabilitation The Scientific and Practical Center "Bonum"', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Materia Medica Holding', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}