Impact of Amantadine on Traumatic Brain Injury

Phase 4

Completed

• Conditions: Trauma, Brain
• Interventions: Drug: Amantadine (100mg) as add on therapy.; Drug: Placebo

• Registration Number: NCT04527289
• Lead Sponsor: Damanhour University

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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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

Study Timeline

• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-22
• Study First Posted: 2020-08-26
• Study Start: 2020-09-30
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amantadine Group	Amantadine (100mg) as add on therapy.	Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen.
Placebo Group	Placebo	Group II are patients who will be managed with the standard regimen.

Primary Outcome Measures

Name	Time	Method
Neurotensin pg/ml	2 weeks	Neurotensin pg/ml by ELISA Kit
Neuron specific enolase (NSE) ng/mL	2 Weeks	Neuron specific enolase (NSE) by ELISA Kit
interleukin-18 (IL-18) pg/ml	2 Weeks	interleukin-18 (IL-18) by ELISA Kit
ICU stay (days)	6 weeks	ICU stay (days)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Elgarbia, Egypt