FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Trial ID or NCT#
NCT05135091
Status
RECRUITING
Purpose
This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).
Official Title
A First-In-Human (FIH) Study of Inhibitory Interneurons (NRTX- 1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
Eligibility Criteria
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- 1. Male or Female, age ≥18 to 752. Focal seizures, clinically defined as unilateral MTLE3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses4. Currently on stable doses (at least 1 month) of approved ASDs5. Single seizure focus confirmed within one hippocampus6. 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 disease2. 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 participation4. History of status epilepticus in the year prior to screening. A history of cluster seizures is permitted.5. Primary or secondary immunodeficiency6. Suicide attempts in the past year7. Severe psychiatric disorders8. Prior lobectomy or LITT procedure9. MRI indicating potential malignant lesion10. Pregnancy, or currently breastfeeding.
Investigator(s)
Kevin Graber, MD
Epilepsy specialist,
Neurophysiologist,
Neurologist
Clinical Professor, Adult Neurology
JaimieÌýHenderson, MD
Functional neurosurgeon,
Epilepsy neurosurgeon,
Pain neurosurgeon,
Movement disorders specialist,
Deep brain stimulation specialist,
Neurosurgeon
John and Jene Blume - Robert and Ruth Halperin Professor, Professor of Neurosurgery and, by courtesy, of Neurology and Neurological Sciences
Contact us to find out if this trial is right for you.
Contact
Jordan Seliger, CRC, MA
650-460-9260
View on