Last updated on April 2019

Clinical Trial of Efficacy and Safety of Tenoten for Children Liquid Dosage Form in the Treatment of Sequelae of Perinatal Injury to Central Nervous System in Children

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sequelae of Perinatal Injury to Central Nervous System
  • Age: - 1 Years
  • Gender: Male or Female
  • Other:
    Full-term infants aged 29 days to 9 months.
    Diagnosis of sequelae of cerebral hypoxic-ischaemic injury and/or grade I or II
    intracranial haemorrhage
    Total Jurba-Mastyukova score of < 27 (but > 12).
    Indicant of physical development within the range of 25-75 centiles.
    Outpatient follow-up with a neurologist.
    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.

You may not be eligible for this study if the following are true:

  • Prior diagnosis of any of the following:
    1. Cerebral ischaemia (grade III). 1.2. Intraventricular haemorrhage (grade III).
    3. Metabolic and toxic metabolic disorders affecting CNS (persistent neonatal
    hypoglycemia, hyperbilirubinemia of various etiologies associated with elevated
    indirect bilirubin levels, and other severe intoxications) 1.4. Intracranial birth
    injury, focal impairments due to brain injuries (pareses and paralyses).
    5. Sequelae of birth injury to spinal cord, cranial nerves and peripheral nervous
    ystem (peripheral pareses and paralyses).
    6. Different types of hydrocephalus. 1.7. Symptomatic epilepsy and epileptic
    yndromes. 1.8. Sequelae of perinatal CNS infectious diseases (injury to CNS caused by
    neonatal sepsis, encephalitis, meningitis, meningoencephalitis, ventriculitis).
    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), disorders of galactose metabolism
    (galactosaemia, Е74.2), other disorders of carbohydrate metabolism (Е74), disorders of
    glycosaminoglycan metabolism (mucopolysaccharidoses, Е76), disorders of aromatic
    amino-acid metabolism (phenylketonuria, tyrosinaemia etc., Е70), disorders of
    branched-chain amino-acid metabolism and fatty-acid metabolism (maple-syrup-urine
    disease, Е71), mitochondrial myopathy (G71.3).
    12. Neurodegenerative diseases, including Huntington disease (G10); disorder of
    copper metabolism (Wilson disease, Е83.0).
    13. Chromosomal abnormalities. 1.14. Congenital anomalies [malformations] and
    deformities, including congenital anomalies of nervous system and malformations of
    internal organs.
    15. Congenital endocrine diseases (congenital hypothyroidism, hypoparathyroidism,
    adrenocortical dysnunction).
    16. Malignant neoplasm/suspected malignant neoplasm
    Acute infectious diseases, exacerbation/decompensation of diseases that may prevent
    the patients' participation in the trial.
    Allergy/intolerance to any of the components of medications used in the treatment.
    Drug addiction, alcohol use in the amount over 2 units of alcohol a day by the
    patient's parent(s)/adopter(s).
    Mental disorders of the patient's parent(s)/adopter(s).
    Participation in other clinical studies for a period prior to and during the course of
    this trial.
    Other conditions preventing the patient from normal participation (e.g., problems
    visiting the doctor regularly, moving home, etc.).
    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 dosing regimen of
    the investigational drug.
    Patients whose parent(s)/adopter(s) are related research staff of the clinical
    investigative site who are directly involved in the study or are the immediate family
    member of the investigator. The immediate family members include husband/wife,
    parents, children or brothers (or sisters), regardless of whether they are natural or
    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).

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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