Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

April 3, 2025 updated by: Noha Mansour, Mansoura University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Daqahlia
      • Mansoura, Daqahlia, Egypt, 35516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Memantine group
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
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
Other: Control group
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
Mild to moderate TBI patients will receive mannitol in case of brain edema to reduce brain swelling and analgesic for headache such as; acetaminophen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days
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) .
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2025

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-88

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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