NCT06422923 A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
| NCT ID | NCT06422923 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Neurona Therapeutics |
| Condition | Epilepsy, Temporal Lobe |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-11-14 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-11-14 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.
Eligibility Criteria
Key Inclusion Criteria: 1. Male or female, age 18-75 years. 2. Subjects of childbearing potential will use highly effective contraception. 3. Proven history of focal seizures of hippocampal origin with bilateral seizure foci confirmed by scalp or intracranial ictal EEG (including confirmation by recordings from responsive neurostimulation \[RNS\] electrodes when applicable). 4. Either 1. bilateral hippocampal sclerosis on MRI (evidenced by increased FLAIR signal intensity in both hippocampi or by visual assessment showing reduced volume compared to normal) or 2. bilateral temporal hypometabolism on 18-Flourodeoxyglucose Positron Emission Tomography (FDG PET) (assessed by visual assessment, comparing temporal regions to frontal/parietal lobe neocortex). In this case, ictal EEG recordings must also include intracranial confirmation. or 3. a combination of unilateral instances of the evidence described in a. and b. (e.g., one side can be evidenced by criterion a. and the other side by criterion b.) MRI or PET scans used for assessment must have been acquired within 3 years of screening. 5. Subject has had at least four clinical focal seizures, including at least two clinical focal seizures with objective manifestations, on average, per month for the 6 months prior to screening. 6. Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs). 7. Current ASM regimen, and doses of other drugs known to affect seizure frequency (e.g., antidepressants), have been stable for at least three months prior to enrollment. 8. Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent. Key Exclusion Criteria: 1. Epilepsy due to other and/or progressive neurologic disease. 2. Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings). 3. MRI indicating potential malignant lesion (low-grade glioma of any type is excluded) in any location or non-malignant potentially epileptogenic lesion outside the hippocampus. Small (\<2 cm) non invasive meningioma, remote from the affected temporal lobe, is not exclusionary. 4. Seizures of non-focal origin. 5. History of status epilepticus in the year prior to screening, as guided by ILAE criteria (Trinka 2015) in the judgement of the PI. A history of cluster seizures is permitted. 6. Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years. 7. Severe psychiatric disorders. 8. Primary or secondary immunodeficiency. 9. Pregnancy, or currently breastfeeding. 10. Suicide attempts in past year. 11. Significant other medical conditions which would impair safe participation.
Contact & Investigator
Eduardo Dunayevich, MD
STUDY DIRECTOR
Neurona Therapeutics
Frequently Asked Questions
Who can join the NCT06422923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Epilepsy, Temporal Lobe. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06422923 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06422923 currently recruiting?
Yes, NCT06422923 is actively recruiting participants. Contact the research team at neuronamedinfo@neuronatx.com for enrollment information.
Where is the NCT06422923 trial being conducted?
This trial is being conducted at Little Rock, United States, Los Angeles, United States, Orange, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06422923 clinical trial?
NCT06422923 is sponsored by Neurona Therapeutics. The principal investigator is Eduardo Dunayevich, MD at Neurona Therapeutics. The trial plans to enroll 10 participants.
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