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A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Site details revised at 17 of 17 sitesv14
  3. Study sites: 16 to 17v13
  4. Study sites: 15 to 16v12
  5. Study sites: 14 to 15v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 13 to 14v10
  2. Study sites: 10 to 13v9
  3. Primary completion date: Jul 15, 2026 to Jun 15, 2027
    • Study sites: 6 to 10
    • Study completion date: Jul 15, 2040 to Jun 15, 2042
    v8
  4. Study sites: 5 to 6v7
  5. Study sites: 4 to 5v6
  6. Phase: Phase 1 to Phase 1/2v5 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Nov 15, 2024 to Nov 14, 2024
    • Eligibility criteria shortened, about 360 words
    • Study description expanded, about 88 words
    • Study title expanded, about 3 words
  7. Start date: Jul 15, 2024 to Nov 15, 2024v4
  8. Study description shortened, about 84 wordsv3
  9. Secondary endpoint revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06422923
Lead Sponsor Neurona Therapeutics
Conditions
(from sponsor)		 Epilepsy, Temporal Lobe
Related terms Epilepsy, Temporal Lobe
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov