Sequelae of Perinatal Brain InjuryPhase 3NCT03159611
Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
A Phase 3 study testing Tenoten for children in people with Sequelae of Perinatal Brain Injury, run by Materia Medica Holding at 10 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 29 days to 9 months
- Conditions the study is for
- Sequelae of Perinatal Brain Injury
- What is being tested?
- Tenoten for children
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 10 sitesRussia
- Study dates
- 19 Feb 2016to 9 Feb 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.).
Show all 21Show fewer
- 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.
- 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).
- Mental disorders of the patient's parent(s)/adoptive parent(s).
- Participation in other clinical studies for a period prior to and during the course of this trial.
- Other conditions complicating the subject's participation in the study (cannot make regular medical visits, moving, etc.).
- 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.
- 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.
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Russia10 sites
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', 420012
Pirogov Russian National Research Medical University
Moscow, 117997
I.M. Sechenov First MSMU
Moscow, 119991
Moscow Regional Research and Clinical Institute ("MONIKI")
Moscow, 129110
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, 614066
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
LLC "Center for DNA Research"
Saratov, 410005
LLC Nebbiolo
Tomsk, 634034
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation
Yaroslavl, 150000
State Budgetary Healthcare Institution of Sverdlovsk Region Children's Clinical Hospital of Rehabilitation The Scientific and Practical Center "Bonum"
Yekaterinburg, 620149
About this study
Official title: Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
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
- Being tested
- Tenoten for children, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenoten for childrenDrug
Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.
PlaceboDrug
Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.
| Study group | Role | What they receive |
|---|---|---|
| Tenoten for children | Experimental | Not described Receives: Drug: Tenoten for children |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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)
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".
Measured: 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)
The Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Consists of Three batteries: Clinical adaptive test (CAT), clinical linguistic and auditory milestone scale (CLAMS), and Gross motor (GM). CAT is the visual-motor problem-solving battery; the score on the CAT is based on the child's performance with the administered items. CLAMS is the language battery of the test; the score on the CLAMS is based on the parent's report of language skill attainment. GM evaluates motor skills; the score on the GM is based on the direct observation of a child and examination by the neurologist. The scores from the CAT/CLAMS+GM are expressed as developmental quotients [DQ = (developmental age/chronologic age)*100]. The full-scale CAT/CLAMS+GM DQ (full-scale DQ) is the mean of the CAT DQ, the CLAMS DQ, and GM DQ. Full-scale DQ ≥ 75 is considered as normal value (the child has a normal development).
Measured: 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)
The Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Consists of Three batteries: Clinical adaptive test (CAT), clinical linguistic and auditory milestone scale (CLAMS), and Gross motor (GM). CAT is the visual-motor problem-solving battery. The score on the CAT is based on the child's performance with the administered items. CLAMS is the language battery of the test. The score on the CLAMS is based on the parent's report of language skill attainment. GM evaluates motor skills. The score on the GM is based on the direct observation of a child and examination by the neurologist. The scores from the CAT/CLAMS+GM are expressed as developmental quotients [DQ = (developmental age/chronologic age)*100]. The full-scale CAT/CLAMS+GM DQ (full-scale DQ) is the mean of the CAT DQ, the CLAMS DQ, and GM DQ. Full-scale DQ ≥ 75 is considered as normal value (the child has a normal development).
Measured: in 12 weeks of the treatment
Clinical Global Impression Scale - Efficacy Index (CGI-EI) Score by the End of the Treatment Course.
The Clinical Global Impressions - Efficacy Index (CGI-EI) scale provide an evaluation of the treatment response. CGI-EI takes account of both therapeutic efficacy and treatment-related adverse events and ranges from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects).
Measured: in 12 weeks of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start19 Feb 2016
- Primary completion9 Feb 2018
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sequelae of Perinatal Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159611
- Sponsor's protocol ID
- MMH-TD-004
- Status last verified
- Aug 2019
- First submitted
- 17 May 2017
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
- ClinicalTrials.gov ID
- NCT03159611
- Acronym / sponsor ID
- MMH-TD-004
- Conditions
- Sequelae of Perinatal Brain Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 9 Feb 2018 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenoten for children | Experimental | Drug: Tenoten for children |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 29 days to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenoten for childrenOral. 10 drops daily, at the same time in the morning, 15 minutes before feeding. | Drug | Tenoten for children |
| PlaceboOral. 10 drops daily, at the same time in the morning, 15 minutes before feeding. | Drug | Placebo |
Primary outcome
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
Time frame: in 12 weeks 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".
4 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: in 12 weeks of the treatment
Clinical Global Impression Scale - Efficacy Index (CGI-EI) Score by the End of the Treatment Course.
Time frame: in 12 weeks of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tenoten for children in people with Sequelae of Perinatal Brain Injury, run by Materia Medica Holding at 10 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: in 12 weeks of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.