Impact of Amantadine on Traumatic Brain Injury

Damanhour University

Status and phase: Completed; Phase 4

Conditions: Trauma, Brain

Treatments: Drug: Amantadine (100mg) as add on therapy.; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04527289

Amantadine on TBI

Details and patient eligibility

About

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).

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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Amantadine Group

Experimental group

Description:

Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen.

Treatment:

Drug: Amantadine (100mg) as add on therapy.

Placebo Group

Placebo Comparator group

Description:

Group II are patients who will be managed with the standard regimen.

Treatment:

Drug: Placebo