Impact of Amantadine on Traumatic Brain Injury

• Sponsor: Damanhour University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04527289
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Trauma, Brain	Drug: Amantadine (100mg) as add on therapy.; Drug: Placebo	Phase 4

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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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

• Study Type: Interventional
• Actual Enrollment: 50 participants
• 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.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)
• Masking Description: double blind
• Primary Purpose: Treatment
• Official Title: Potential Impact of Amantadine on Traumatic Brain Injury Outcomes
• Actual Study Start Date: Sep 30, 2020
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amantadine Group Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen.	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; Other Names: PK-merz
Placebo Comparator: Placebo Group Group II are patients who will be managed with the standard regimen.	Drug: Placebo; patients will be managed with placebo as add on to the standard regimen.

Outcome Measures

Primary Outcome Measures

1. Neurotensin pg/ml [6 weeks]

   Neurotensin pg/ml by ELISA Kit

2. Neuron specific enolase (NSE) ng/mL [6 Weeks]

   Neuron specific enolase (NSE) by ELISA Kit

3. interleukin-18 (IL-18) pg/ml [6 Weeks]

   interleukin-18 (IL-18) by ELISA Kit

4. (GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15) [6 weeks]

   noumber of GCS to describe the level of consciousness in a person following a traumatic brain injury.

5. ICU stay (days) [6 weeks]

   ICU stay (days)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospital	Tanta	Elgarbia	Egypt	31527

Sponsors and Collaborators

• Damanhour University

Investigators

• Study Director: Rehab H Werida, Lecturer, Damanhour University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Ciaramella A, Della Vedova C, Salani F, Viganotti M, D'Ippolito M, Caltagirone C, Formisano R, Sabatini U, Bossù 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.
• 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. Review.

• Responsible Party: Rehab Werida, Principal Investigator, Damanhour University
• ClinicalTrials.gov Identifier: NCT04527289
• Other Study ID Numbers: Amantadine on TBI
• First Posted: Aug 26, 2020
• Last Update Posted: Dec 21, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rehab Werida, Principal Investigator, Damanhour University: traumatic brain injury (TBI); Interleukin-18 (IL-18); Neuron specific enolase (NSE); Neurotensin (NT)
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Amantadine

Study Results

No Results Posted as of Dec 21, 2021