Skip to content
DataLookout
Start free
Menu

NCT05066217

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

StatusRecruiting
PhasePhase 3
SponsorEpygenix
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 14 versions: 13 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 61 → 71 locations
  2. Trial sites expanded: 58 → 61 locations
  3. Trial sites expanded: 55 → 58 locations
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 10 entries
  4. Trial sites expanded: 26 → 55 locationsv11
  5. Trial sites expanded: 20 → 26 locationsv10
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 4 to 20v9
  2. Site details revised at 1 of 4 sitesv8
  3. Study sites: 2 to 4v7
  4. Start date changed from estimate of Apr 8, 2025 to Apr 9, 2025v6
  5. Phase: Phase 2 to Phase 3v5 Show 14 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 24 to 260
    • Primary completion date: Feb 1, 2025 to Nov 1, 2026
    • Start date: May 1, 2024 to Apr 8, 2025
    • Primary endpoint revised
    • Study sites: 0 to 2
    • Study completion date: Feb 1, 2025 to Nov 1, 2029
    • Interventions: Clemizole HCl (Drug), Placebo to match EPX-100 (Drug) to Clemizole HCl (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 534 words
    • Secondary endpoints expanded, about 76 words
    • Study description shortened, about 57 words
    • Study arms: 2 to 3
    • Collaborators expanded, about 4 words
    • Study title expanded, about 1 word
  6. Primary and study completion dates: Jul 1, 2023 to Feb 1, 2025
    • Start date: Oct 1, 2022 to May 1, 2024
    v4
  7. Enrollment target: 36 to 24
    • Start date: Feb 1, 2022 to Oct 1, 2022
    • Primary endpoint revised
    • Study title revised
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent Change in CMMS-28
Timeframe: From Baseline Period up to 16 weeks

Secondary (9)

Proportion of Participants with ≥50% Reduction in CMMS-28
Percent Change in CMMS-28 Seizure-free Days
Clinical Global Impression of Change (CGI-C) Score
Caregiver Global Impression of Change (CaGI-C) Score
Caregiver Global Impression of Change in Seizure Intensity/Duration (CaGI-CSID) Score
Show 4 moreShow less
Change in Quality of Life Inventory (QI)-Disability Score
Percent Change per 28 Days in the Number of Seizure Free Days
Percent Change in CMMS-28
Incidence of Treatment-Emergent Adverse Events (TEAEs)

Arms and interventions

PlaceboPlacebo comparator

Participants will receive their first dose of study drug following randomization.

Double-blind clemizole HClExperimental

Participants will receive their first dose of study drug following randomization.

Open-label clemizole HClExperimental

Eligible participants who complete the DB Period will have the option to continue in the OLE Period, during which they will receive clemizole HCl for up to 3 years.

Drugs: Clemizole HCl, Placebo

Sites

71 sites in 10 countries

United States 22, China 18, Italy 7, Spain 6, India 5, Serbia 4, Poland 3, Romania 3, Turkey (Türkiye) 2, Hungary 1