Impact of Amantadine on Traumatic Brain Injury
Condition: Trauma, Brain
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      Proposal Steps

        1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy,
           Damanhour University.

        2. All participants agreed to take part in this clinical study and provide informed
           consent.

        3. Patients will be enrolled if they present with clinical signs of trauma, from Emergency
           department at Tanta University Hospital

        4. Complete physical, laboratory, radiological assessment will be done for all patients

        5. Serum samples will be collected for measuring the biomarkers.

        6. 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.

        7. All patients will be followed up during 6 weeks period.

        8. At the end of 6 weeks, prognosis biomarkers will be withdrawn.

        9. Statistical tests appropriate to the study design will be conducted to evaluate the
           significance of the results.

       10. Measuring outcome: The primary outcome is to compare the effect of adding amantadine on
           recovery rate and neurological complications in trauma patients.

       11. 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.
    

Intervention name(s): Amantadine (100mg) as add on therapy.; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Amantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube; patients will be managed with placebo as add on to the standard regimen.
Other intervention name(s): PK-merz
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary purpose: Treatment
Keywords: traumatic brain injury (TBI); Interleukin-18 (IL-18); Neuron specific enolase (NSE); Neurotensin (NT)