Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy

What Was Tested

This registered phase 2 trial tested Cerebrolysin.

Cerebral palsy (CP) is the most frequent cause of motor handicap among children.

The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per person.

Associated disabilities as mental retardation, delayed speech development add psychological burden of the disease on the family as well as economic burden.

It had two arms (groups): Cerebrolysin (experimental) and Conventional (no intervention).

Nerve growth factor Cerebrolysin will be given to the intervention group.

These children will receive conventional treatment for cerebral palsy.

The registry classes the interventions as drug.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 3 months up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Cerebral palsy with mental retardation. Severe perinatal brain insult.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: severe growth retardation; gastrostomy tube feeding; intractable seizures.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Cerebrolysin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

Being open-label, the Cerebrolysin study did not mask who received what.

It started in 2014-04 with completion listed for 2016-04.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: neurodevelopment (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cerebrolysin in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.