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Two-Drug cocktail shows promise for awakening traumatic brain injury patients

NCT ID NCT06052787

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding two drugs—cerebrolysin and amantadine sulfate—to standard care helps people with moderate to severe traumatic brain injury recover in the ICU. 150 adults aged 18-70 took part. Researchers measured consciousness, disability, and recovery over 6 weeks. The goal was to see if the combination improves outcomes more than standard treatment alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

150 people

The number who actually took part.

Started

Sep 2023

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * History of intracranial interventions as well as ischemic or hemorrhagic stroke. * Any neurological or non-neurological condition independent from TBI that might influence the functional outcome or other efficacy outcome measures. * Clear clinical signs of intoxication influencing the evaluation, in the investigator's judgment. * Patients with penetrating brain injury. * Pregnancy or lactation. * Patient with sever renal impairment (creatinine clearance \> 30 ml/ minute).

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

Contacts and locations

Locations

  • Faculty of medicine - Ain shams university

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.