Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU

What Was Tested

In this phase 3 trial, researchers set out to test Cerebrolysin.

It had three arms (groups): standard of care (no intervention), standard of care + Cerebrolysin (experimental) and standard of care + Cerebrolysin + Amantadine sulfate (experimental).

The registry classes the interventions as drug.

More on the Plan

Sixty-nine million individuals worldwide are estimated to sustain a TBI each year.

Traumatic brain injury (TBI) is a non-degenerative, non-congenital insult to the brain from an external mechanical force, possibly leading to permanent or temporary impairment of cognitive, physical, and psychosocial functions, with an associated diminished or altered state of consciousness.

There is growing evidence that medications may speed recovery by enhancing some neurological functions without impacting others.

It stimulates neuronal survival and differentiation, axonal growth and sprouting, the formation of new synapses, and neurogenesis in the dentate gyrus.

Who Took Part

150 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age between 18 and 70 years. Clinical diagnosis of head injury with moderate to severe TBI and a Glasgow coma scale (GCS) score of 7-12 at the time of hospital admission. Pre-hospital intubation/sedation/paralysis was accepted if the GCS score had been assessed before intubation/sedation/paralysis by trained staff.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history of intracranial interventions as well as ischemic or hemorrhagic stroke; clear clinical signs of intoxication influencing the evaluation, in the investigator's judgment; patients with penetrating brain injury.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind 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.

As a double-blind Cerebrolysin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-09-01 with completion listed for 2025-05-30.

It ran at 1 site in Egypt.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: The Glasgow Coma Scale (GCS). Disability rating-scale for severe head trauma (DRS). Coma Recovery Scale-Revised (CRS-R) (time frame: CRS-R will be compared over the 4 weeks of treatment and during 2-weeks after discontinuation of treatment).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cerebrolysin in 150 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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