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Trial record 7 of 154 for:    AMANTADINE

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

Tracking Information
First Submitted Date  ICMJE August 22, 2020
First Posted Date  ICMJE August 26, 2020
Last Update Posted Date August 27, 2020
Estimated Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • Neurotensin pg/ml [ Time Frame: 6 weeks ]
    Neurotensin pg/ml by ELISA Kit
  • Neuron specific enolase (NSE) ng/mL [ Time Frame: 6 Weeks ]
    Neuron specific enolase (NSE) by ELISA Kit
  • interleukin-18 (IL-18) pg/ml [ Time Frame: 6 Weeks ]
    interleukin-18 (IL-18) by ELISA Kit
  • (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.
  • ICU stay (days) [ Time Frame: 6 weeks ]
    ICU stay (days)
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2020)
  • Neurotensin pg/ml [ Time Frame: 6 weeks ]
    Neurotensin pg/ml by ELISA Kit
  • Neuron specific enolase (NSE) ng/mL [ Time Frame: 6 Weeks ]
    Neuron specific enolase (NSE) by ELISA Kit
  • interleukin-18 (IL-18) pg/ml [ Time Frame: 6 Weeks ]
    interleukin-18 (IL-18) by ELISA Kit
  • Total Glasgow Coma Scale score [ Time Frame: 6 weeks ]
    noumber of GCS
  • ICU stay (days) [ Time Frame: 6 weeks ]
    ICU stay (days)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Amantadine on Traumatic Brain Injury
Official Title  ICMJE Potential Impact of Amantadine on Traumatic Brain Injury Outcomes
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Trauma, Brain
Intervention  ICMJE
  • 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
  • Drug: Placebo
    patients will be managed with placebo as add on to the standard regimen.
Study Arms  ICMJE
  • Experimental: Amantadine Group
    Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen.
    Intervention: Drug: Amantadine (100mg) as add on therapy.
  • Placebo Comparator: Placebo Group
    Group II are patients who will be managed with the standard regimen.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rehab H Werida, Lecturer +201005359968 rehabwrieda@pharm.dmu.edu.eg
Contact: Mennatullah G Elmalky, PharmD 0201010006215 Mennashahin1993@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04527289
Other Study ID Numbers  ICMJE Amantadine on TBI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rehab Werida, Damanhour University
Study Sponsor  ICMJE Damanhour University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rehab H Werida, Lecturer Damanhour University
PRS Account Damanhour University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP