Health TrialsbyHealthPanel

Memantine as an Additive Therapy in Patients With Traumatic Brain Injury

ConditionsMild Traumatic Brain InjuryModerate Traumatic Brain Injury (TBI)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Memantine groupActive comparator 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

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.

Time frame
30 days

Secondary outcomes

1

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

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.

Time frame
3 days
2

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

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

Time frame
3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: