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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 July 2025 |
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Main ID: |
NCT06422923 |
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Date of registration:
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15/05/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)
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Scientific title:
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A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Temporal Lobe Epilepsy (MTLE) |
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Date of first enrolment:
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November 14, 2024 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06422923 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Contact type:
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Name:
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Sheri Madrid, BS, BA |
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Address:
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Telephone:
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949-500-0027 |
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Email:
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sheri@neuronatx.com |
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Affiliation:
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Contact type:
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Name:
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John Hixson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neurona Therapeutics |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epilepsy, Temporal Lobe
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Intervention(s)
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Biological: NRTX-1001
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Primary Outcome(s)
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Incidence of Serious Adverse Events at end of month 12
[Time Frame: 12 months after treatment]
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Secondary Outcome(s)
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Change in frequency of clinical seizures
[Time Frame: 12 months after treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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| Results available: |
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| URL: |
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| Date Posted: |
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