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

NCT03159611 | Completed Phase 3 Results

• 1 other identifier: MMH-TD-004
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Sequelae of Perinatal Brain Injury

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With a 4 and More Point Increase of the Total Score According to Jurba-Mastyukova Psychomotor Development Scale by the End of the Treatment

  The Jurba-Mastyukova scale is meant to evaluate motor and mental development of 1-12-month-old infants. 10 developmental domains are evaluated every month. The evaluation of each domain is based on a 4-point system (the optimal development equals 3 points, its absence = 0 points). The maximum score is 30 points; 27-29 points are considered as "age-appropriate normal value"; 23-26 points - as "an absolute risk group"; 13-22 points - as "developmental retardation"; below 13 points - as "severe global developmental delay".

  in 12 weeks of the treatment

Secondary Outcomes (4)

• Percentage of Patients With Normal Psychomotor Development (≥ 27 Scores on Jurba-Mastyukova Scale) by the End of Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)

  in 12 weeks of the treatment

• Mean Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Score by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)

  in 12 weeks of the treatment

• Percentage of Patients With Normal Psychomotor Development (CATS/CLAMS + Gross Motor Developmental Quotients Score ≥ 75) by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)

  in 12 weeks of the treatment

• Clinical Global Impression Scale - Efficacy Index (CGI-EI) Score by the End of the Treatment Course.

  in 12 weeks of the treatment

Study Arms (2)

Tenoten for children

EXPERIMENTAL

Drug: Tenoten for children

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tenoten for children DRUG

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

Tenoten for children

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 29 Days - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Previously diagnosed lesions, diseases and conditions:
• 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).
• Intracranial birth injury, focal impairments due to brain injuries (pareses and paralyses).
• Sequelae of birth injury to spinal cord, cranial nerves and peripheral nervous system (peripheral pareses and paralyses).
• 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).
• Infectious diseases including congenital diseases (cytomegalovirus infection, rubella, herpesvirus or enterovirus infection, toxoplasmosis, syphilis, HIV infection, etc.).
• Chronic respiratory diseases originating in the perinatal period, including bronchopulmonary dysplasia.
• 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).
• Neurogenerative diseases including Huntington disease (G10), copper metabolism disorder (Wilson disease, Е83.0).
• Chromosomal abnormalities. 1.14. Congenital anomalies \[malformations\] and deformities including congenital anomalies of nervous system and malformations of internal organs.
• Congenital endocrine diseases (congenital hypothyroidism, hypoparathyroidism, adrenocortical dysfunction).
• Malignant neoplasm / suspected malignant neoplasm.
• Acute infectious disease, exacerbation / decompensation of diseases that may prevent the patients' participation in the clinical study.
• Allergy/intolerance of any of the study treatment medications components.
• Drug addiction, alcohol use in the volume over 2 alcohol units/day by the subject's parent(s)/adoptive parent(s).

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

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

I.M. Sechenov First MSMU

Moscow, 119991, Russia

Location

Moscow Regional Research and Clinical Institute ("MONIKI")

Moscow, 129110, Russia

Location

Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"

Perm, 614066, Russia

Location

State budgetary institution of public health of the Samara region "Samara City Children's Clinical Hospital No. 1 named after N.N. Ivanova"

Samara, 443079, Russia

Location

LLC "Center for DNA Research"

Saratov, 410005, Russia

Location

LLC Nebbiolo

Tomsk, 634034, Russia

Location

Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation

Yaroslavl, 150000, 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: Michael Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• 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 19, 2017
• Study Start: February 19, 2016
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: August 8, 2019
• Results First Posted: April 8, 2019

Record last verified: 2019-08

Locations

RU (10)