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

NCT03159611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2019-08-08

Study results available
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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

Interventions

DRUG

Tenoten for children

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Materia Medica Holding

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-19
Primary Completion
2018-02-09
Completion
2018-02-09

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159611 on ClinicalTrials.gov