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Memantine Hydrochloride for Subdural Hematoma

(TASD Trial)

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called Memantine to help elderly patients recover better after brain surgery. The goal is to improve recovery and reduce neurological problems. Memantine has been used to treat Alzheimer's disease and other neurological disorders.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are using NMDA antagonists or acetylcholinesterase inhibitors. If you are on these medications, you would need to stop them to join the trial.

Is memantine hydrochloride safe for humans?

Memantine has been used safely in treating Alzheimer's disease and other dementias, with studies showing it is generally well-tolerated. However, there have been reports of potential side effects like bradycardia (slow heart rate) and altered mental status in specific cases.12345

How does the drug memantine hydrochloride differ from other treatments for subdural hematoma?

Memantine hydrochloride is unique because it is an excitatory amino acid (EAA) antagonist that has been used for neurodegenerative diseases like Alzheimer's, but it is now being explored for subdural hematoma to prevent brain damage from reduced blood flow. Unlike standard treatments that focus on surgical removal of the hematoma, memantine targets the chemical processes in the brain to protect it from further injury.26789

Eligibility Criteria

This trial is for adults aged 18-100 who've had surgery for chronic subdural hematoma and experienced spreading depolarization within 48 hours post-operation. They must have an electrode strip placed during surgery. It's not for those with severe liver or kidney issues, known allergies to memantine, current memantine users, women not using dual contraception, or patients needing large craniotomy.

Inclusion Criteria

I have had surgery for a slow bleeding in my brain.
I am between 18 and 100 years old.
I had an electrode strip placed during surgery for seizure monitoring.
See 1 more

Exclusion Criteria

You are allergic to memantine.
I cannot eat or receive food through a tube.
I am taking medication for memory or muscle control.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Surgery and Initial Monitoring

Subjects undergo surgery for chronic or subacute subdural hematoma and are monitored for spreading depolarizations and seizures using a recording electrode placed during surgery.

1-2 days
Inpatient monitoring

Treatment

Subjects with detected spreading depolarization are randomized to receive either memantine or placebo for 7 days.

7 days
Daily administration (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of neurological deficits and adverse events.

90 days
Periodic follow-up visits

Treatment Details

Interventions

  • Memantine Hydrochloride
  • Placebo
Trial OverviewThe TASD study is testing if Memantine Hydrochloride can reduce neurological problems like weakness or confusion after cSDH surgery by blocking certain brain signals (NMDA-R antagonism). Some participants will get the real drug while others a placebo to compare outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MemantineExperimental Treatment1 Intervention
Subjects will be given memantine 10mg PO/ NG BID for 7 days
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be given identical placebo syrup PO/NG BID for 7 days

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials
393
Recruited
3,526,000+

Findings from Research

Memantine is an FDA-approved treatment for moderate to severe Alzheimer's disease, demonstrating both safety and efficacy as a standalone therapy or in combination with cholinesterase inhibitors.
Research suggests that memantine may also have potential therapeutic effects in other neuropsychiatric conditions, warranting further investigation into its broader applications.
Memantine: a review of studies into its safety and efficacy in treating Alzheimer's disease and other dementias.Thomas, SJ., Grossberg, GT.[2022]
Memantine, while generally well-tolerated for neurocognitive protection during cranial radiotherapy, can cause altered mental status, as demonstrated in a case involving an 18-year-old male with medulloblastoma who required ICU admission after starting the medication.
The patient's symptoms improved significantly after memantine was withheld, highlighting the need for clinicians to be cautious and monitor for potential neurocognitive side effects when prescribing memantine, especially in pediatric patients.
Life-threatening altered mental status secondary to memantine in an adolescent undergoing cranial radiotherapy for medulloblastoma.Kim, KN., Shah, YB., Croy, C., et al.[2023]
Memantine, used for treating moderate to severe Alzheimer's disease, has been shown to have a favorable safety and tolerability profile, with adverse events similar in frequency to those experienced by patients on placebo, based on data from 2311 patients in six trials lasting at least 24 weeks.
The analysis indicates that both short- and long-term treatment with memantine is safe, with minimal adverse effects, and discontinuation rates due to side effects were comparable between memantine and placebo groups.
Memantine for the treatment of Alzheimer's disease: tolerability and safety data from clinical trials.Farlow, MR., Graham, SM., Alva, G.[2021]

References

Memantine: a review of studies into its safety and efficacy in treating Alzheimer's disease and other dementias. [2022]
Effects of memantine and MK-801 on ischemia in an experimental model of acute subdural hematoma. [2013]
Life-threatening altered mental status secondary to memantine in an adolescent undergoing cranial radiotherapy for medulloblastoma. [2023]
Memantine for the treatment of Alzheimer's disease: tolerability and safety data from clinical trials. [2021]
Does memantine induce bradycardia? A study in the French PharmacoVigilance Database. [2013]
Memantine hydrochloride in the treatment of dementia subtypes. [2013]
Effects of hypertonic/hyperoncotic treatment and surgical evacuation after acute subdural hematoma in rats. [2013]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Features of memantine action profile in cholinergic deficit and intracerebral posttraumatic hematoma (hemorrhagic stroke) models in rats]. [2019]
Effectiveness and safety of generic memantine hydrochloride manufactured in China in the treatment of moderate to severe Alzheimer's disease: a multicenter, double-blind randomized controlled trial. [2021]