Trauma, BrainPhase 4NCT04527289
Impact of Amantadine on Traumatic Brain Injury
A Phase 4 study testing Amantadine (100mg) as add on therapy. in people with Trauma, Brain, run by Damanhour University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Trauma, Brain
- What is being tested?
- Amantadine (100mg) as add on therapy.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2020to 30 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Adult patients will be enrolled if they present with clinical signs of trauma brain injury
Who cannot join
- 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)
Show all 9Show fewer
- Severe brain disease (For example CVA history or brain tumour)
- Renal failure with GFR lower than 60 ml/min
- Patients with unknown identity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Impact of Amantadine on Traumatic Brain Injury Outcomes
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).
Read the detailed description
Proposal Steps
- 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.
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.
- Conditions
- Trauma, Brain
- Being tested
- Amantadine (100mg) as add on therapy., Placebo
- Keywords
- traumatic brain injury (TBI), Interleukin-18 (IL-18), Neuron specific enolase (NSE), Neurotensin (NT)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine (100mg) as add on therapy.Drug
Also called PK-merz
Amantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube
PlaceboDrug
patients will be managed with placebo as add on to the standard regimen.
| Study group | Role | What they receive |
|---|---|---|
| Amantadine Group | Experimental | Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen. Receives: Drug: Amantadine (100mg) as add on therapy. |
| Placebo Group | Placebo comparator | Group II are patients who will be managed with the standard regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurotensin pg/ml
Neurotensin pg/ml by ELISA Kit
Measured: 2 weeks
Neuron specific enolase (NSE) ng/mL
Neuron specific enolase (NSE) by ELISA Kit
Measured: 2 Weeks
interleukin-18 (IL-18) pg/ml
interleukin-18 (IL-18) by ELISA Kit
Measured: 2 Weeks
ICU stay (days)
ICU stay (days)
Measured: 6 weeks
Secondary outcomes (2)
(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.
Measured: 6 weeks
GCS-E
The Glasgow Outcome Scale-Extended (GOS-E)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start30 Sep 2020
- Primary completion1 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trauma, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Lecturer, Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527289
- Sponsor's protocol ID
- Amantadine on TBI
- Status last verified
- Apr 2023
- First submitted
- 22 Aug 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26165872Bharosay 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.
PubMed 23542317Ciaramella 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.
PubMed 24080899
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Impact of Amantadine on Traumatic Brain Injury Outcomes
- ClinicalTrials.gov ID
- NCT04527289
- Acronym / sponsor ID
- Amantadine on TBI
- Conditions
- Trauma, Brain
- Keywords
- traumatic brain injury (TBI), Interleukin-18 (IL-18), Neuron specific enolase (NSE), Neurotensin (NT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Amantadine Group | Experimental | Drug: Amantadine (100mg) as add on therapy.Group, I are patients who will receive amantadine (100mg) as add on therapy to the standard regimen. |
| Placebo Group | Placebo comparator | Drug: PlaceboGroup II are patients who will be managed with the standard regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Adult patients will be enrolled if they present with clinical signs of trauma brain injury
Key exclusion criteria (9 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amantadine (100mg) as add on therapy.Also: PK-merzAmantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube | Drug | Amantadine Group |
| Placebopatients will be managed with placebo as add on to the standard regimen. | Drug | Placebo Group |
Primary outcome
Neurotensin pg/ml
Time frame: 2 weeks
Neurotensin pg/ml by ELISA Kit
Neuron specific enolase (NSE) ng/mL
Time frame: 2 Weeks
Neuron specific enolase (NSE) by ELISA Kit
interleukin-18 (IL-18) pg/ml
Time frame: 2 Weeks
interleukin-18 (IL-18) by ELISA Kit
ICU stay (days)
Time frame: 6 weeks
ICU stay (days)
2 secondary outcomes
(GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15).
Time frame: 6 weeks
GCS-E
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 26165872Stelmaschuk 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.
- Background: PubMed 23542317Bharosay 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.
- Background: PubMed 24080899Ciaramella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehab H Werida, Lecturer study director
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amantadine (100mg) as add on therapy. in people with Trauma, Brain, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurotensin pg/ml (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04527289, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.