Impact of Amantadine on Traumatic Brain Injury

Trauma, Brain Clinical Trial

Official title:

Potential Impact of Amantadine on Traumatic Brain Injury Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527289
• Other study ID #: Amantadine on TBI
• Status: Completed
• Phase: Phase 4
• Start date: September 30, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: April 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Trauma, Brain

Intervention

Drug:
• 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
• Placebo
patients will be managed with placebo as add on to the standard regimen.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Elgarbia

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bharosay A, Bharosay VV, Varma M, Saxena K, Sodani A, Saxena R. Correlation of Brain Biomarker Neuron Specific Enolase (NSE) with Degree of Disability and Neurological Worsening in Cerebrovascular Stroke. Indian J Clin Biochem. 2012 Apr;27(2):186-90. doi: 10.1007/s12291-011-0172-9. Epub 2011 Nov 8. — View Citation

Ciaramella A, Della Vedova C, Salani F, Viganotti M, D'Ippolito M, Caltagirone C, Formisano R, Sabatini U, Bossu P. Increased levels of serum IL-18 are associated with the long-term outcome of severe traumatic brain injury. Neuroimmunomodulation. 2014;21(1):8-12. doi: 10.1159/000354764. Epub 2013 Sep 26. — View Citation

Stelmaschuk S, Will MC, Meyers T. Amantadine to Treat Cognitive Dysfunction in Moderate to Severe Traumatic Brain Injury. J Trauma Nurs. 2015 Jul-Aug;22(4):194-203; quiz E1-2. doi: 10.1097/JTN.0000000000000138. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurotensin pg/ml	Neurotensin pg/ml by ELISA Kit	2 weeks
Primary	Neuron specific enolase (NSE) ng/mL	Neuron specific enolase (NSE) by ELISA Kit	2 Weeks
Primary	interleukin-18 (IL-18) pg/ml	interleukin-18 (IL-18) by ELISA Kit	2 Weeks
Primary	ICU stay (days)	ICU stay (days)	6 weeks
Secondary	(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
Secondary	GCS-E	The Glasgow Outcome Scale-Extended (GOS-E)	6 months