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

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).

Timeline

Start

2016-02-19

Primary completion

2018-02-09

Completion

2018-02-09

Outcome

Met primary endpoint

registry analysis (superiority test); Tenoten for Children vs Placebo; p = 0.002; Fisher Exact NCT03159611 ↗

Drugs

Indications