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NCT Number: NCT06914310

Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

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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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Moderate Traumatic Brain Injury (TBI) Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location contact

Shimaa Khaled Saber

CONTACT

[email protected]

01060383641

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 3 days

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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