Impact of Amantadine on Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT04527289|
Recruitment Status : Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Trauma, Brain||Drug: Amantadine (100mg) as add on therapy. Drug: Placebo||Phase 4|
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants agreed to take part in this clinical study and provide informed consent.
- Patients will be enrolled if they present with clinical signs of trauma, from Emergency department at Tanta University Hospital
- Complete physical, laboratory, radiological assessment will be done for all patients
- Serum samples will be collected for measuring the biomarkers.
- 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.
- All patients will be followed up during 6 weeks period.
- At the end of 6 weeks, prognosis biomarkers will be withdrawn.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcome: The primary outcome is to compare the effect of adding amantadine on recovery rate and neurological complications in trauma patients.
- Results, conclusion, discussion and recommendations will be given.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
|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|
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.
patients will be managed with placebo as add on to the standard regimen.
- 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)
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
|Contact: Rehab H Werida, Lectureremail@example.com|
|Contact: Mennatullah G Elmalky, PharmD||0201010006215||Mennashahin1993@gmail.com|
|Study Director:||Rehab H Werida, Lecturer||Damanhour University|