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NCT07572812

A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

StatusRecruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Start date changed from estimate of Aug 20, 2026 to Sep 5, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Site details revised at 3 of 3 sites
  2. Start date: May 20, 2026 to Aug 20, 2026v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Timeframe: From baseline to 6 Months post-treatment

Secondary (5)

Change from baseline in total and subtype seizure frequency
Responder rates (≥50% and ≥75% reduction) in total and subtype seizure frequency
Seizure free rate
Incidence and severity of AEs/SAEs related to surgery, transplanted cells, and/or immunosuppressive therapy
Incidence and severity of all AEs/SAEs

Arms and interventions

UX-GIP001Experimental

Two dose levels will be planned. Each patient only receives one corresponding dose of UX-GIP001.

Drugs: UX-GIP001

Sites

3 sites in 1 country