Impact of Amantadine on Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-10-30

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).

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Detailed Description

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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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

Conditions

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Trauma, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind

Study Groups

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Amantadine Group

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

Group Type EXPERIMENTAL

Amantadine (100mg) as add on therapy.

Intervention Type DRUG

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

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Amantadine (100mg) as add on therapy.

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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PK-merz

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No