Mild Traumatic Brain InjuryPhase 2/3NCT06914310
Memantine as an Additive Therapy in Patients With Traumatic Brain Injury
A Phase 2/3 study testing Memantine and Mannitol in people with Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury (TBI), run by Mansoura University at 1 site in Egypt.
Trial summary
Memantine has shown promise in mitigating secondary brain injury in previous studies. One study demonstrated that early memantine administration in moderate TBI patients resulted in lower serum neuron-specific enolase levels and improved Glasgow Coma Scale scores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury (TBI)
- What is being tested?
- Memantine and Mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2025to 30 Nov 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 70 years of age
- Patients mild (GCS 13-15) to moderate (GCS 9-12) TBI were assessed for the study eligibility.
Who cannot join
- 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 diseases.
- Malignancies.
- Pregnancy.
- Patients unable to tolerate enteral feeding.
- More than 24 hours (h) since traumatic injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Shimaa Khaled Saber, 01060383641, shimaa_khaled95@yahoo.com
About this study
Memantine has shown promise in mitigating secondary brain injury in previous studies. One study demonstrated that early memantine administration in moderate TBI patients resulted in lower serum neuron-specific enolase levels and improved Glasgow Coma Scale scores. However, other trials investigating memantine's impact on long-term cognitive function in TBI patients have yielded mixed results. There is a need for well-controlled studies to determine the efficacy of memantine in improving neurological and cognitive outcomes in patients with TBI.
Read the detailed description
The current study aims to evaluate the cognitive function, neuroprotective effect, and S-100β serum level effect of Memantine in patients with mild to moderate traumatic brain injury (TBI) patients.
- Being tested
- Memantine, Mannitol
- Keywords
- Traumatic Brain Injury (TBI), Memantine, S100β
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Memantine will be given either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital and then continued for 3 weeks. The memantine dose in the first 7 days is 30 mg twice daily, while during the remaining 3 weeks the dose is 10 mg twice daily
MannitolDrug
Mild to moderate TBI patients will receive mannitol in case of brain edema to reduce brain swelling and analgesic for headache such as; acetaminophen.
| Study group | Role | What they receive |
|---|---|---|
| Memantine group | Active comparator | Mild to moderate TBI patients will receive memantine. It will be given either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital and then continued for 3 weeks. The memantine dose in the first 7 days is 30 mg twice daily, while during the remaining 3 weeks the dose is 10 mg twice daily Receives: Drug: Memantine |
| Control group | Other | Mild to moderate TBI patients will be managed by mannitol or hypertonic saline to reduce brain swelling and analgesic for headache such as; acetaminophen. Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the 2 groups regarding mean Montreal Cognitive Assessment (MOCA) scores at the end of treatment
Score rage: 0 - 30. Normal cognition: 26 - 30, mild cognitive impairment: 18 - 25, moderate cognitive impairment: 10 - 17 and severe cognitive impairment: less than 10.
Measured: 30 days
Secondary outcomes (2)
The differences between study groups in Glasgow Coma Scale (GCS) score.
The differences between study groups in GCS scores over 3 days. The score ranges from 3 (Minimum score = deep coma or death) to 15 (Maximum score = fully awake and oriented). Traumatic brain injury (TBI) is graded as mild, moderate, or severe on the basis of the level of consciousness or Glasgow coma scale (GCS) score after resuscitation. Mild TBI score ranges from 13 to 15, moderate TBI ranges from 9 to 13; while severe TBI ranges from 3 to 8.
Measured: 3 days
The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B)
The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B) .
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start25 Mar 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Mansoura 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914310
- Sponsor's protocol ID
- 2024-88
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine as an Additive Therapy in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06914310
- Acronym / sponsor ID
- 2024-88
- Keywords
- Traumatic Brain Injury (TBI), Memantine, S100β
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 6 Apr 2025 (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.
Memantine has shown promise in mitigating secondary brain injury in previous studies. One study demonstrated that early memantine administration in moderate TBI patients resulted in lower serum neuron-specific enolase levels and improved Glasgow Coma Scale scores. However, other trials investigating memantine's impact on long-term cognitive function in TBI patients have yielded mixed results. There is a need for well-controlled studies to determine the efficacy of memantine in improving neurological and cognitive outcomes in patients with TBI.
Detailed description
The current study aims to evaluate the cognitive function, neuroprotective effect, and S-100β serum level effect of Memantine in patients with mild to moderate traumatic brain injury (TBI) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine group | Active comparator | Drug: MemantineMild to moderate TBI patients will receive memantine. It will be given either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital and then continued for 3 weeks. The memantine dose in the first 7 days is 30 mg twice daily, while during the remaining 3 weeks the dose is 10 mg twice daily |
| Control group | Other | Drug: MannitolMild to moderate TBI patients will be managed by mannitol or hypertonic saline to reduce brain swelling and analgesic for headache such as; acetaminophen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18 and 70 years of age
- Patients mild (GCS 13-15) to moderate (GCS 9-12) TBI were assessed for the study eligibility.
Key exclusion criteria (8 listed)
- 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 diseases.
- Malignancies.
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 |
|---|---|---|
| MemantineMemantine will be given either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital and then continued for 3 weeks. The memantine dose in the first 7 days is 30 mg twice daily, while during the remaining 3 weeks the dose is 10 mg twice daily | Drug | Memantine group |
| MannitolMild to moderate TBI patients will receive mannitol in case of brain edema to reduce brain swelling and analgesic for headache such as; acetaminophen. | Drug | Control group |
Primary outcome
The difference between the 2 groups regarding mean Montreal Cognitive Assessment (MOCA) scores at the end of treatment
Time frame: 30 days
Score rage: 0 - 30. Normal cognition: 26 - 30, mild cognitive impairment: 18 - 25, moderate cognitive impairment: 10 - 17 and severe cognitive impairment: less than 10.
2 secondary outcomes
The differences between study groups in Glasgow Coma Scale (GCS) score.
Time frame: 3 days
The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B)
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Mild Traumatic Brain Injury
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Memantine and Mannitol in people with Mild Traumatic Brain Injury and Moderate Traumatic Brain Injury (TBI), run by Mansoura 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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Apr 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the 2 groups regarding mean Montreal Cognitive Assessment (MOCA) scores at the end of treatment (time frame: 30 days). 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 6 Apr 2025.