FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Launched by NEURONA THERAPEUTICS · Nov 16, 2021

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called NRTX-1001, which involves injecting special nerve cells into the brain to help people with a type of epilepsy known as mesial temporal lobe epilepsy. This condition is often resistant to standard medications, meaning that patients continue to have seizures even after trying several different treatments. The main goals of the study are to see if this new therapy is safe and if it can help reduce the number of seizures in patients.

To participate in this trial, you must be between 18 and 65 years old and have been diagnosed with focal seizures, specifically temporal lobe epilepsy, that have not responded to at least two different medications. You should also be taking a stable dose of your current epilepsy medications for at least a month. The study is looking for individuals who have been experiencing an average of two or more seizures every 28 days over the past six months. If you decide to join, you will receive the nerve cell treatment, and the researchers will closely monitor your health and seizure activity to determine how well it works. This trial is currently looking for participants, so if you or someone you know fits the criteria, it may be worth discussing with a healthcare provider.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male or Female, age ≥18 to 75
• • 2. Focal seizures, clinically defined as unilateral MTLE
• • 3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses
• • 4. Currently on stable doses (at least 1 month) of approved ASDs
• • 5. Single seizure focus confirmed within one hippocampus
• • 6. Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focal seizures per 28-day period with objective manifestations or more severe types, over the 6 months prior to the Screening Visit.
• • 7. Considered (by Investigator) to be a candidate for temporal lobectomy (TL) or Laser Interstitial Thermal Therapy (LITT) following evaluation at a qualified epilepsy surgery program (National Association of Epilepsy Centers \[NAEC\] Level 4).
• Key Exclusion Criteria:
• • 1. Epilepsy due to other and/or progressive neurologic disease
• • 2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.
• • 3. Significant other medical conditions which would impair safe participation
• • 4. History of status epilepticus in the year prior to screening. A history of cluster seizures is permitted.
• • 5. Primary or secondary immunodeficiency
• • 6. Suicide attempts in the past year
• • 7. Severe psychiatric disorders
• • 8. Prior lobectomy or LITT procedure
• • 9. MRI indicating potential malignant lesion
• • 10. Pregnancy, or currently breastfeeding.