Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

Phase 2

Not yet recruiting

• Conditions: Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury (TBI)
• Interventions: Drug: Memantine; Drug: Mannitol

• Registration Number: NCT06914310
• Lead Sponsor: Mansoura University

Brief 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.

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 Timeline

• Study Start: 2025-03-25
• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-08-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Memantine group	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	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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) .
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.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Daqahlia, Egypt