Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Amantadine on Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04527289
Recruitment Status : Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Rehab Werida, 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).

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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: Double (Participant, Investigator)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: Potential Impact of Amantadine on Traumatic Brain Injury Outcomes
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Neurotensin pg/ml [ Time Frame: 6 weeks ]
    Neurotensin pg/ml by ELISA Kit

  2. Neuron specific enolase (NSE) ng/mL [ Time Frame: 6 Weeks ]
    Neuron specific enolase (NSE) by ELISA Kit

  3. interleukin-18 (IL-18) pg/ml [ Time Frame: 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) [ Time Frame: 6 weeks ]
    noumber of GCS to describe the level of consciousness in a person following a traumatic brain injury.

  5. ICU stay (days) [ Time Frame: 6 weeks ]
    ICU stay (days)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527289


Contacts
Layout table for location contacts
Contact: Rehab H Werida, Lecturer +201005359968 rehabwrieda@pharm.dmu.edu.eg
Contact: Mennatullah G Elmalky, PharmD 0201010006215 Mennashahin1993@gmail.com

Sponsors and Collaborators
Damanhour University
Investigators
Layout table for investigator information
Study Director: Rehab H Werida, Lecturer Damanhour University
Publications:
Layout table for additonal information
Responsible Party: Rehab Werida, Principal Investigator, Damanhour University
ClinicalTrials.gov Identifier: NCT04527289    
Other Study ID Numbers: Amantadine on TBI
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rehab Werida, Damanhour University:
traumatic brain injury (TBI)
Interleukin-18 (IL-18)
Neuron specific enolase (NSE)
Neurotensin (NT)
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents