What side effects are associated with this type of intervention?

Common treatments for Mesial Temporal Lobe Epilepsy (MTLE) that reduce neuronal excitability include antiepileptic drugs like lamotrigine (LTG) and valproic acid (VPA). LTG can cause dizziness, headache, double vision, and skin rashes, including severe reactions like Stevens-Johnson syndrome. VPA is associated with weight gain, tremor, hair loss, gastrointestinal issues, and serious adverse effects like liver toxicity and pancreatitis. Both drugs can also lead to cognitive side effects, such as memory and concentration difficulties.

What prior FDA approvals exist?

FDA-approved treatments for Mesial Temporal Lobe Epilepsy typically include antiepileptic drugs (AEDs) such as levetiracetam, lamotrigine, and valproic acid, which work by stabilizing neuronal membranes and reducing excitability. While these drugs are effective for many patients, some cases of MTLE are drug-resistant, leading to the exploration of alternative treatments like the investigational use of inhibitory nerve cells. This novel approach aims to directly reduce neuronal excitability by introducing inhibitory cells into the brain, offering a potential new avenue for patients who do not respond to traditional AEDs.

What other types of research exist?

Promising novel alternatives for treating mesial temporal lobe epilepsy in 2024 include: 1) Lacosamide, which has shown efficacy in reducing epileptiform activity in hippocampal tissue. 2) Electrical stimulation of the thalamic reticular nucleus (TRN), which has demonstrated the ability to suppress limbic motor seizures. 3) Ganaxolone, a synthetic neuroactive steroid, approved for treating seizures in specific genetic epilepsy syndromes and showing potential for broader applications.

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Neural Cell Therapy

NRTX-1001 Neural Cell Therapy for Epilepsy

Phase 1 & 2

Recruiting

Research Sponsored by Neurona Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Seizure frequency averages ≥2 per 28-day period over the 6 months prior to screening

Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses

Must not have

Epilepsy due to other and/or progressive neurologic disease

Primary or secondary immunodeficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Summary

This trial tests if injecting special brain cells into the brain can help patients with hard-to-treat epilepsy. The new cells release a calming chemical to reduce seizures. Patients will also take medicines to prevent their bodies from rejecting the new cells.

Who is the study for?

This trial is for adults aged 18 to 65 with drug-resistant mesial temporal lobe epilepsy. Participants must have a history of focal seizures, be on stable epilepsy medication doses, and have confirmed seizure focus in one temporal lobe. They should not have attempted suicide in the past year, severe psychiatric disorders, pregnancy or breastfeeding status, progressive neurological diseases other than epilepsy, significant medical conditions that impair participation, immunodeficiency or chronic intracranial devices.

What is being tested?

The study tests NRTX-1001 neural cell therapy's safety and effectiveness against placebo (sham comparator) in reducing seizure frequency. It involves a single stereotactic injection of inhibitory nerve cells directly into the brain of subjects with unilateral mesial temporal lobe epilepsy who haven't responded to at least two anti-seizure drugs.

What are the potential side effects?

Potential side effects may include adverse reactions related to brain injections such as headache, bleeding or infection at the injection site; immune response issues due to foreign cells; and any unforeseen complications from altering brain cell activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had an average of 2 or more seizures every month for the last 6 months.

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I still have seizures despite trying at least 2 different seizure medications.

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I have focal seizures known as temporal lobe epilepsy.

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My seizures are confirmed to originate from one side of my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My epilepsy is caused by a progressive neurological condition.

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I have a condition that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of serious or severe AEs

Secondary study objectives

Change in seizure frequency

Responder rate

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: NRTX-1001 (Stage 2)Experimental Treatment1 Intervention

Up to 20 subjects.

Group II: NRTX-1001 (Stage 1)Experimental Treatment1 Intervention

Up to 10 subjects.

Group III: Sham Comparator (Stage 2)Placebo Group1 Intervention

Up to 10 subjects.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mesial Temporal Lobe Epilepsy (MTLE) focus on reducing neuronal excitability to prevent seizures. Antiseizure medications like carbamazepine, levetiracetam, and valproate stabilize neuronal membranes and inhibit excessive electrical activity by targeting sodium channels, GABA receptors, or calcium channels. Surgical interventions, such as anterior temporal lobectomy, aim to remove or disconnect the epileptogenic focus in the temporal lobe. The trial involving inhibitory nerve cells introduces a novel approach by directly reducing neuronal excitability through the introduction of cells that inhibit overactive neurons, potentially offering a more targeted and effective treatment for drug-resistant MTLE patients.