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ARGUSNCT04462770

A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

StatusRecruiting
PhasePhase 3
SponsorEpygenix
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

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Record History

All 38 versions: 36 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Trial sites expanded: 68 → 86 locations
    • Secondary endpoints: 12 to 7
    • Study description shortened, about 21 words
  2. Study sites: 69 to 68
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 5 of 12 entries
  3. Trial sites expanded: 60 → 69 locationsv36
  4. Study sites: 58 to 60
    • Eligibility criteria expanded, about 1 word
    v35
  5. Primary completion date: Apr 1, 2026 to Apr 2027
    • Study sites: 46 to 58
    • Study completion date: May 1, 2029 to May 2029
    • Study description shortened, about 5 words
    v34
Show 30 earlier versionsHide 30 earlier versions
  1. Site details revised at 2 of 46 sitesv33
  2. Primary endpoints: 1 to 2v32 Show 4 more changesShow less
    • Study sites: 44 to 46
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 8 to 12
    • Study description shortened, about 1 word
  3. Phase: Phase 2 to Phase 3v31 Show 9 more changesShow less
    • Enrollment target: 100 to 150
    • Primary endpoint revised
    • Study sites: 27 to 44
    • Study completion date: May 1, 2026 to May 1, 2029
    • Interventions: EPX-100 (clemizole HCl) (Drug), Placebo (Drug) to Clemizole HCl (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 368 words
    • Secondary endpoints: 12 to 8
    • Study description expanded, about 9 words
    • Study arms: 2 to 3
  4. Primary completion date: Dec 19, 2024 to Apr 1, 2026v30 Show 9 more changesShow less
    • Primary endpoint revised
    • Study completion date: Dec 19, 2024 to May 1, 2026
    • Interventions: EPX-100 (Clemizole HCl) (Drug), Placebo (Drug) to EPX-100 (clemizole HCl) (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 116 words
    • Secondary endpoints revised (12)
    • Site details revised at 4 of 27 sites
    • Study description shortened, about 3 words
    • Collaborators expanded, about 4 words
    • Study title shortened, about 4 words
  5. Primary and study completion dates: Oct 19, 2023 to Dec 19, 2024
    • Trial status: Completed to Recruiting
    • Site details revised at 27 of 27 sites
    • Collaborators shortened, about 5 words
    v29
  6. Trial status: Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 2024 to Oct 19, 2023
    • Site details revised at 27 of 27 sites
    • Collaborators expanded, about 5 words
    v28
  7. Study sites: 24 to 27v27
  8. Study sites: 13 to 24v26
  9. Study description expanded, about 19 wordsv25
  10. Site contacts updated at 2 of 13 sitesv24
  11. Primary and study completion dates pushed to Dec 2024
    • Study sites: 11 to 13
    v23
  12. Study sites: 9 to 11v22
  13. Enrollment target: 60 to 100v21 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 8 to 9
    • Eligibility criteria expanded, about 136 words
    • Secondary endpoints: 9 to 12
    • Study description shortened, about 106 words
  14. Eligibility criteria shortened, about 33 words
    • Secondary endpoints revised (9)
    • Study description shortened, about 11 words
    v18
  15. Site details revised at 1 of 8 sitesv17
  16. Site details revised at 1 of 8 sitesv16
  17. Study sites: 9 to 8v15
  18. Study sites: 8 to 9v14
  19. Study sites: 7 to 8v13
  20. Site contacts updated at 3 of 7 sitesv12
  21. Site details revised at 1 of 7 sitesv11
  22. Study sites: 3 to 7v10
  23. Primary endpoint revisedv9 Show 5 more changesShow less
    • Primary completion date: Oct 2022 to Sep 2022
    • Study completion date: Oct 2022 to Sep 2023
    • Secondary endpoints: details revised at 3 of 9 entries
    • Study sites revised (3)
    • Study title expanded, about 1 word
  24. Study sites: 2 to 3v8
  25. Enrollment target: 56 to 60v7 Show 4 more changesShow less
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints revised (9)
    • Study description shortened, about 7 words
    • Study title shortened, about 1 word
  26. Enrollment target: 24 to 56v6 Show 5 more changesShow less
    • Primary completion date: Oct 2021 to Oct 2022
    • Start date changed from estimate of Sep 2020 to Sep 15, 2020
    • Study description expanded, about 10 words
    • Eligibility criteria expanded, about 2 words
    • Collaborators shortened, about 4 words
  27. Site details revised at 1 of 2 sitesv5
  28. Start date: Jul 2020 to Sep 2020
    • Site contacts updated at 2 of 2 sites
    v4
  29. Trial status: Not Yet Recruiting to Recruiting
    • Secondary endpoints: details revised at 4 of 9 entries
    • Study sites revised (2)
    v3
  30. Study sites: 0 to 2
    • Secondary endpoints: details revised at 2 of 9 entries
    • Study title shortened, about 1 word
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline
Timeframe: From Baseline up to Week 16
European Union: Percent Change in CMS-28 in the Maintenance Period Relative to Baseline
Timeframe: From Baseline up to Week 16

Secondary (7)

Percentage of Participants with >=50% reduction in CMS-28 Relative to Baseline
Number of Countable Motor Seizure-free Days Relative to Baseline
Clinical Global Impression of Improvement - Clinician (CGII-C) Score
Clinical Global Impression of Improvement - Participant/Caregiver (CGII-P) Score
Percent Change in All Seizures Relative to Baseline
Show 2 moreShow less
Incidence of Rescue Anti-epileptic Drug (AED) Use Relative to Baseline
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Arms and interventions

Double-blind Phase: Clemizole HClExperimental

Participants will receive clemizole HCl twice a day (BID).

Double-blind Phase: PlaceboPlacebo comparator

Participants will receive matching placebo BID.

OLE Phase: Clemizole HClExperimental

Participants will receive clemizole HCL BID.

Drugs: Clemizole HCl, Placebo

Sites

86 sites in 11 countries

United States 31, China 18, India 12, Argentina 4, Brazil 4, Canada 4, Georgia 3, Poland 3, United Kingdom 3, Hungary 2, Spain 2