Cell Transplantation for Drug-Resistant Epilepsy (NTE-001) NRTX-1001

Purpose of this Study

We are doing this study to find out if an experimental cell therapy called NRTX-1001 (the study drug) is a safe and effective treatment for drug-resistant mesial temporal lobe epilepsy (MTLE). We want to know if the study drug can reduce seizures in people who are not getting relief from conventional treatments.

Who Can Participate?

Eligibility

Adults ages 18-65 who:
  • Are diagnosed with temporal lobe epilepsy that causes focal seizures
  • Have tried at least 2 different medications to control seizures without success
  • Are having at least 2 seizures per month for the past 6 months
  • Do not have an indwelling intracranial device (shunt, neurostimulator, etc.) placed in the brain
  • Have never received any type of gene or cell therapy
For more information about who can join this study, please contact the study team at Jodi.Lennon@duke.edu or 919-613-9129.

Age Range

18-65

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will:
  • Have a surgical procedure to introduce a population of cells into the part of your brain that causes your seizures
  • Take immunosuppressant medication (medicines that reduce the immune system) before you have the surgical procedure and for up to 1 year after the procedure is done
  • Have blood draws
  • Have imaging scans (EEG & MRI)
After the procedure is done, you will return to our clinic annually for follow-up study visits (years 3-15). We will continue to keep in touch with you (phone calls every 3 months) during years 3-15. You can find more information about this study on its website: https://www.neuronatherapeutics.com/nte001/

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

Yes

Study Details

Full Title

A First-in-human (FIH) Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)

Principal Investigator

Derek
Southwell

Protocol Number

PRO00108759

NCT ID

NCT05135091

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov