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Completed

NCT Number: NCT04527289

Impact of Amantadine on Traumatic Brain Injury

The aim of this study is to evaluate whether the addition of amantadine to the management regimen of traumatic brain injury patients would have a favorable effect on recovery and neurological complications in association with prognosis biomarkers Interleukin-18 (IL-18), Neuron-specific enolase (NSE) and (Neurotensin).

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Key information

Conditions

Trauma, Brain Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospital

Tanta, Elgarbia, 31527, Egypt

About this study

Proposal Steps

  • Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
  • All participants agreed to take part in this clinical study and provide informed consent.
  • Patients will be enrolled if they present with clinical signs of trauma, from Emergency department at Tanta University Hospital
  • Complete physical, laboratory, radiological assessment will be done for all patients
  • Serum samples will be collected for measuring the biomarkers.
  • All enrolled 50 patients will be divided into two groups; Group I are patients who will receive amantadine as added on therapy. Group II are patients who will be managed with the standard regimen.
  • All patients will be followed up during 6 weeks period.
  • At the end of 6 weeks, prognosis biomarkers will be withdrawn.
  • Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  • Measuring outcome: The primary outcome is to compare the effect of adding amantadine on recovery rate and neurological complications in trauma patients.
  • Results, conclusion, discussion and recommendations will be given.

Methodology

  • 50 Patients will be randomized equally to the assigned study groups
  • Prognosis biomarkers (IL-18, NSE and Neurotensin) will be measured using ELISA
  • Conventional routine tests (including renal function tests) will be assessed
  • Patients will be evaluated clinically (such as Glasgow score…) for recovery rate for neurological complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria

•Adult patients will be enrolled if they present with clinical signs of trauma brain injury

  • Exclusion criteria
  • Age lower than 18
  • Females with positive pregnancy test
  • Known congestive heart failure or ischemic heart disease
  • Any injury disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias)
  • Penetrating head trauma
  • Need for any operation (laparotomy or craniotomy)
  • Severe brain disease (For example CVA history or brain tumour)
  • Renal failure with GFR lower than 60 ml/min
  • Patients with unknown identity

Treatment and study plan

Amantadine (100mg) as add on therapy.

Drug

Amantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube

Other names: PK-merz

Placebo

Drug

patients will be managed with placebo as add on to the standard regimen.

Primary outcomes

  1. Neurotensin pg/ml

    Time frame: 2 weeks

    Neurotensin pg/ml by ELISA Kit

  2. Neuron specific enolase (NSE) ng/mL

    Time frame: 2 Weeks

    Neuron specific enolase (NSE) by ELISA Kit

  3. interleukin-18 (IL-18) pg/ml

    Time frame: 2 Weeks

    interleukin-18 (IL-18) by ELISA Kit

  4. ICU stay (days)

    Time frame: 6 weeks

    ICU stay (days)

Secondary outcomes

  1. (GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15).

    Time frame: 6 weeks

    number of GCS to describe the level of consciousness in a person following a traumatic brain injury.

  2. GCS-E

    Time frame: 6 months

    The Glasgow Outcome Scale-Extended (GOS-E)

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

Potential Impact of Amantadine on Traumatic Brain Injury Outcomes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2020
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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