Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-19

Study Completion Date

2018-02-09

Brief Summary

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Purpose of the study:

* To assess the clinical efficacy of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial haemorrhage).
* To assess the safety of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial haemorrhage).

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Detailed Description

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Conditions

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Sequelae of Perinatal Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tenoten for children

Group Type EXPERIMENTAL

Tenoten for children

Intervention Type DRUG

Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.

Interventions

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Tenoten for children

Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.

Intervention Type DRUG

Placebo

Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Full-term infants aged 29 days to 9 months.
2. Diagnosis of Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischemia and/or mild-to-moderate intracranial hemorrhage).
3. Total Jurba-Mastyukova score of \< 27 (but \> 12).
4. Physical development parameters within 25-27 centiles.
5. Neurologist's outpatient observation.
6. Information sheet (informed consent form) for parents/adoptive parents for participation in the clinical study signed by the child's parents/adoptive parents.

Exclusion Criteria

1. Previously diagnosed lesions, diseases and conditions:

1.1. Cerebral ischemia (grade III). 1.2. Intraventricular hemorrhage (grade III). 1.3. Metabolic and toxic disorders affecting central nervous system (persistent neonatal hypoglycemia, hyperbilirubinemia associated with elevated indirect bilirubin, and other severe conditions).

1.4. Intracranial birth injury, focal impairments due to brain injuries (pareses and paralyses).

1.5. Sequelae of birth injury to spinal cord, cranial nerves and peripheral nervous system (peripheral pareses and paralyses).

1.6. Different types of hydrocephalus. 1.7. Symptomatic epilepsy and epileptic syndromes. 1.8. Sequelae of perinatal central nervous system (CNS) infectious diseases (injury to CNS caused by neonatal sepsis, encephalitis, meningitis, meningoencephalitis, ventriculitis).

1.9. Infectious diseases including congenital diseases (cytomegalovirus infection, rubella, herpesvirus or enterovirus infection, toxoplasmosis, syphilis, HIV infection, etc.).

1.10. Chronic respiratory diseases originating in the perinatal period, including bronchopulmonary dysplasia.

1.11. Hereditary metabolic diseases including glycogen storage disease (glycogenoses, E74.0), galactose metabolism disorders (galactosemia, Е74.2), other carbohydrate metabolism disorders (Е74), glucosaminoglycan metabolism disorders (mucopolysaccharidoses, Е76), aromatic amino-acid metabolism disorders (phenylketonuria, tyrosinemia, etc, Е70), branched-chain amino-acid and fatty-acid metabolism disorders (maple-syrup-urine disease, Е71), mitochondrial myopathy (G71.3).

1.12. Neurogenerative diseases including Huntington disease (G10), copper metabolism disorder (Wilson disease, Е83.0).

1.13. Chromosomal abnormalities. 1.14. Congenital anomalies \[malformations\] and deformities including congenital anomalies of nervous system and malformations of internal organs.

1.15. Congenital endocrine diseases (congenital hypothyroidism, hypoparathyroidism, adrenocortical dysfunction).

1.16. Malignant neoplasm / suspected malignant neoplasm.
2. Acute infectious disease, exacerbation / decompensation of diseases that may prevent the patients' participation in the clinical study.
3. Allergy/intolerance of any of the study treatment medications components.
4. Drug addiction, alcohol use in the volume over 2 alcohol units/day by the subject's parent(s)/adoptive parent(s).
5. Mental disorders of the patient's parent(s)/adoptive parent(s).
6. Participation in other clinical studies for a period prior to and during the course of this trial.
7. Other conditions complicating the subject's participation in the study (cannot make regular medical visits, moving, etc.).
8. Subjects whose parent(s)/adoptive parent(s), from the investigator's point of view, will not follow the study requirements or comply with the dosing regimen.
9. Patients whose parent(s)/adoptive parent(s) are related research staff of the clinical investigative site who are directly involved in the study or is a close relative of the investigator. Close relatives include spouse, parents, children or brothers (sisters) regardless of whether they are biological or adoptive ones.
10. Patients whose parent(s)/adoptive parent(s) is working in OOO "NPF "Materia Medica Holding", i.e. is the company official, temporary contract worker or an appointed official responsible for the study or their close relatives.

Minimum Eligible Age

29 Days

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No