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New treatment option for Epilepsy, Temporal Lobe
Official title A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
ClinicalTrials.gov ID: NCT06422923
What this study is testing
What is NRTX-1001?
NRTX-1001 is an investigational medicine, being studied as a potential treatment for epilepsy, temporal lobe.
Also referred to as GABA-secreting interneurons.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female, age 18-75 years.
- people of childbearing potential will use highly effective contraception.
- Proven history of focal seizures of hippocampal origin with bilateral seizure foci confirmed by scalp or intracranial ictal EEG (including...
- Either
- bilateral hippocampal sclerosis on MRI (evidenced by increased FLAIR signal intensity in both hippocampi or by visual assessment showing reduced...
You likely can't join if
- Epilepsy due to other and/or progressive neurologic disease.
- Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings).
- MRI indicating potential malignant lesion (low-grade glioma of any type is excluded) in any location or non-malignant potentially epileptogenic...
- Seizures of non-focal origin.
- 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...
- Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years.
See the full eligibility criteria
- Male or female, age 18-75 years.
- people of childbearing potential will use highly effective contraception.
- 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...
- Either
- 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
- 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...
- 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...
- 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.
- Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs).
- 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.
- Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent. Key
- Epilepsy due to other and/or progressive neurologic disease.
- Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings).
- 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...
- Seizures of non-focal origin.
- 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.
- Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years.
- Severe psychiatric disorders.
- Primary or secondary immunodeficiency.
- Pregnancy, or currently breastfeeding.
- Suicide attempts in past year.
- Significant other medical conditions which would impair safe participation.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Syracuse, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; San Diego, California, United States; San Francisco, California, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.