Impact of Amantadine on Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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.

Official Title
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Potential Impact of Amantadine on Traumatic Brain Injury Outcomes

Conditions
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Trauma, Brain

Intervention / Treatment
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* Drug: Amantadine (100mg) as add on therapy.
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All enrolled 50 patients will be divided into two groups; Group I are patients who will receive amantadine as add on therapy. Group II are patients who will be managed with the standard regimen.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amantadine Group<br>Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen. | Drug: Amantadine (100mg) as add on therapy.<br>* Amantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube<br>* Other names: PK-merz;|
| Placebo Comparator: Placebo Group<br>Group II are patients who will be managed with the standard regimen. | Drug: Placebo<br>* patients will be managed with placebo as add on to the standard regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurotensin pg/ml | Neurotensin pg/ml by ELISA Kit | 2 weeks | 
| Neuron specific enolase (NSE) ng/mL | Neuron specific enolase (NSE) by ELISA Kit | 2 Weeks | 
| interleukin-18 (IL-18) pg/ml | interleukin-18 (IL-18) by ELISA Kit | 2 Weeks | 
| ICU stay (days) | ICU stay (days) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15). | number of GCS to describe the level of consciousness in a person following a traumatic brain injury. | 6 weeks | 
| GCS-E | The Glasgow Outcome Scale-Extended (GOS-E) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury (TBI), Interleukin-18 (IL-18), Neuron specific enolase (NSE), Neurotensin (NT)