Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

NCT06914310 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-88
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury (TBI)

Keywords

Traumatic Brain Injury (TBI); Memantine; S100β

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (2)

• The differences between study groups in Glasgow Coma Scale (GCS) score.

  3 days

• The difference between the two study groups in mean serum level of S100 calcium-binding protein B (S100B)

  3 days

Study Arms (2)

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

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.

Drug: Mannitol

Interventions

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

Memantine group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Interventions

Memantine; Mannitol

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Sugar Alcohols; Alcohols; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 6, 2025
• Study Start: March 25, 2025
• Primary Completion: August 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)