Traumatic Brain InjuryNCT05531383
Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
A study testing Memantine Hydrochloride in people with Traumatic Brain Injury, run by Minia University at 1 site in Egypt.
Trial summary
Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Memantine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2021to 9 Jul 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe closed TBI with initial GCS of 4-12
- Age from 18 to 65 years of both sexes
- Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI.
Who cannot join
- Open TBI or patients who would need open craniotomy later on.
- Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours, acute or chronic renal insufficiency, hepatic diseases, autoimmune abnormalities, history of epileptic fits and known malignancies.
- Patients with chest, cardiac, abdominal trauma or any other trauma requiring mechanical ventilation.
- Patients with body mass index (BMI) <18.5 or > 34.9 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury
Read the detailed description
Studying the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) \& serum NSE levels in participents with moderate to severe TBI as well as outcome.
Investigators evaluate prognostic effect of memantine on participents with moderate to severe TBI. also to estimate which of platelet, platelet/lymphocyte ratio (PLR), C reactive protein (CRP) or serum NSE levels will be affected by administration of memantine in participents with moderate to severe TBI as a predictor of outcome.
- Conditions
- Traumatic Brain Injury
- Being tested
- Memantine Hydrochloride
- 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.
Memantine HydrochlorideDrug
Also called Namenda
study the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) \& serum NSE levels in patients with moderate to severe TBI as well as their outcome.
| Study group | Role | What they receive |
|---|---|---|
| Control group (group 1) | No intervention | Patients in the control group (group 1) No memantine administration |
| Treatment group (group 2) | Active comparator | in addition to the standard treatment, they will receive memantine (30 mg) twice daily, either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital. The memantine dose administered in our study was based on the maximum dose of 60 mg/day reported in prior human studies Receives: Drug: Memantine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis of moderate to sever head injury
Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start26 Nov 2021
- Primary completion20 Nov 2023 (estimated)
- Study completion9 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Nemr Youssef, Minia University
- Investigators
- Ibrahim Talaat, MD, Study chair, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531383
- Sponsor's protocol ID
- 140-2021
- Status last verified
- Sep 2022
- First submitted
- 8 Mar 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05531383
- Acronym / sponsor ID
- 140-2021
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 9 Jul 2024 (estimated)
- First posted
- 8 Sep 2022 (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.
Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury
Detailed description
Studying the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) \& serum NSE levels in participents with moderate to severe TBI as well as outcome.
Investigators evaluate prognostic effect of memantine on participents with moderate to severe TBI. also to estimate which of platelet, platelet/lymphocyte ratio (PLR), C reactive protein (CRP) or serum NSE levels will be affected by administration of memantine in participents with moderate to severe TBI as a predictor of outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (group 1) | No intervention | –Patients in the control group (group 1) No memantine administration |
| Treatment group (group 2) | Active comparator | Drug: Memantine Hydrochloridein addition to the standard treatment, they will receive memantine (30 mg) twice daily, either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital. The memantine dose administered in our study was based on the maximum dose of 60 mg/day reported in prior human studies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe closed TBI with initial GCS of 4-12
- Age from 18 to 65 years of both sexes
- Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI.
Key exclusion criteria (4 listed)
- Open TBI or patients who would need open craniotomy later on.
- Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours, acute or chronic renal insufficiency, hepatic diseases, autoimmune abnormalities, history of epileptic fits and known malignancies.
- Patients with chest, cardiac, abdominal trauma or any other trauma requiring mechanical ventilation.
- Patients with body mass index (BMI) <18.5 or > 34.9 kg/m2.
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 |
|---|---|---|
| Memantine HydrochlorideAlso: Namendastudy the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) \& serum NSE levels in patients with moderate to severe TBI as well as their outcome. | Drug | Treatment group (group 2) |
Primary outcome
prognosis of moderate to sever head injury
Time frame: 7days
Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
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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.
Ibrahim Talaat, MD study chair
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memantine Hydrochloride in people with Traumatic Brain Injury, run by Minia 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
prognosis of moderate to sever head injury (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2022.