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

NCT06052787 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-11-19

No results posted yet for this study

Summary

The goal of this interventional study is to Measure the potential benefits of combined administration of cerebrolysin and amantadine sulfate as an add-on therapy to the standard management of patients admitted to the ICU with traumatic brain injury.

Conditions

Interventions

DRUG

Cerebrolysin

Cerebrolysin, a mixture of free amino acids and low molecular weight peptides, has a neurotrophic factor-like activity with immediate pleiotropic neuroprotective activity and long-term multimodal effects on endogenous post-lesional regulation. Cerebrolysin has been suggested to exert beneficial effects on neurobehavioural functions, cognitive performance , and neuro-motor recovery , as part of initial therapy in severe and moderate acute TBI.

DRUG

amantadine sulfate

The dopaminergic agonist amantadine enhances presynaptic dopamine release and inhibits dopamine reuptake, resulting in an increased amount of dopamine in the synaptic cleft. Amantadine may also increase the density of postsynaptic dopamine receptors and alter the conformation of these receptors. Amantadine acts as an NMDA receptor antagonist, blocking glutamate, an NMDA channel activator. This effect may be responsible for amantadine's possible beneficial effect soon after TBI

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ragab D Elshabasy · faculty of medicine - Ain shams university

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-05-30
Completion
2025-08-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

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 NCT06052787 on ClinicalTrials.gov