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Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

Study acronym: EPIC
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 33 to 35v34
  2. Study sites: 32 to 33v33
  3. Study sites: 31 to 32v32
  4. Study sites: 30 to 31v31
  5. Phase: Phase 1/2 to Phase 3v30 Show 9 more changesShow less
    • Enrollment target: 58 to 88
    • Primary completion date: Feb 2028 to Feb 2029
    • Primary endpoints: 1 to 2
    • Study completion date: Feb 2042 to Sep 2043
    • Secondary endpoints revised (2)
    • Site contacts updated at 30 of 30 sites
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 1 word
    • Study title expanded, about 3 words
Show 28 earlier versionsHide 28 earlier versions
  1. Study sites: 29 to 30v29
  2. Site contacts updated at 29 of 29 sitesv28
  3. Primary completion date: May 2025 to Feb 2028v27 Show 7 more changesShow less
    • Enrollment target: 40 to 58
    • Study sites: 22 to 29
    • Study completion date: May 2026 to Feb 2042
    • Interventions: NRTX-1001 (Biological), Sham Comparator (Procedure) to NRTX-1001 (Biological), NRTX-1001 (Biological), Sham Comparator (Procedure)
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 64 words
  4. Study sites: 21 to 22v26
  5. Study sites: 19 to 21v25
  6. Study sites: 18 to 19v24
  7. Study sites: 17 to 18v23
  8. Site contacts updated at 1 of 17 sitesv22
  9. Study sites: 16 to 17v21
  10. Study sites: 15 to 16v20
  11. Site contacts updated at 3 of 15 sitesv19
  12. Study sites: 13 to 15v18
  13. Study sites: 12 to 13v17
  14. Study sites: 11 to 12
    • Eligibility criteria revised
    v16
  15. Study sites: 10 to 11v15
  16. Study sites: 9 to 10v14
  17. Site contacts updated at 5 of 9 sitesv13
  18. Study sites: 8 to 9
    • Eligibility criteria expanded, about 42 words
    v12
  19. Study sites: 7 to 8v11
  20. Study sites: 6 to 7v10
  21. Collaborators expanded, about 6 wordsv9
  22. Study sites: 5 to 6
    • Start date changed from estimate of Jun 2022 to Jun 16, 2022
    v8
  23. Study sites: 4 to 5
    • Start date: May 16, 2022 to Jun 2022
    v7
  24. Study sites: 3 to 4
    • Primary completion date: Mar 2025 to May 2025
    • Study completion date: Mar 2026 to May 2026
    • Start date: Apr 18, 2022 to May 16, 2022
    v6
  25. Study sites: 2 to 3v5
  26. Study sites: 1 to 2
    • Start date: Mar 30, 2022 to Apr 18, 2022
    v4
  27. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Apr 2022 to Mar 30, 2022
    v3
  28. Start date: Dec 2021 to Apr 2022v2
  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 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).
Trial Details
NCT Number NCT05135091
Lead Sponsor Neurona Therapeutics
Collaborators: California Institute for Regenerative Medicine (CIRM)
Conditions
(from sponsor)		 Mesial Temporal Lobe Epilepsy
Related terms Epilepsy, Seizures
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov