Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

NCT06914310 — Phase 2 / Phase 3, Not yet recruiting, 80 participants, Mansoura University

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Registry	NCT06914310
Status	Not yet recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	80 (Estimated)
Sponsor	Mansoura University (Other)
Conditions	Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury (TBI)
Interventions	Memantine, Mannitol (Drug)
Dates	start 2025-03-25 (estimated), primary completion 2025-08-30 (estimated), completion 2025-11-30 (estimated), first posted 2025-04-06, last updated 2025-04-06
Locations	1 site in Egypt

-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. 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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Memantine group	Active comparator	Drug: Memantine	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
Control group	Other	Drug: Mannitol	Mild to moderate TBI patients will be managed by mannitol or hypertonic saline to reduce brain swelling and analgesic for headache such as; acetaminophen.

Memantine (Drug): 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
Mannitol (Drug): Mild to moderate TBI patients will receive mannitol in case of brain edema to reduce brain swelling and analgesic for headache such as; acetaminophen.

+Outcome measures

Primary outcomes

The difference between the 2 groups regarding mean Montreal Cognitive Assessment (MOCA) scores at the end of treatment [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.

Secondary outcomes

The differences between study groups in Glasgow Coma Scale (GCS) score. [3 days]: 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.
The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B) [3 days]: The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B) .

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Patients between 18 and 70 years of age
2. Patients mild (GCS 13-15) to moderate (GCS 9-12) TBI were assessed for the study eligibility.

Exclusion Criteria:

1. Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours.
2. Acute or chronic renal insufficiency.
3. Hepatic diseases.
4. Autoimmune diseases.
5. Malignancies.
6. Pregnancy.
7. Patients unable to tolerate enteral feeding.
8. More than 24 hours (h) since traumatic injury

+Locations (1)

Facility	City	Country	Status
Mansoura University	Al Mansurah, Dakahlia Governorate	Egypt