NCT03159611

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Materia Medica Holding · Industry
• Sex: All
• Age: 29 Days – 9 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2016-02-19
• Primary completion: 2018-02-09
• Completion: 2018-02-09
• First posted: 2017-05-19
• Last updated: 2019-08-08
• Results posted: 2019-04-08

Locations

10 sites across 1 country: Russia