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X-ACKTNCT05667142

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 32 versions: 32 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 138 → 141 locations
  2. Eligibility criteria expanded, about 19 words
    • Study description revised
    • Site details revised at 15 of 138 sites
  3. Site details revised at 6 of 138 sitesv30
  4. Site details revised at 2 of 138 sitesv29
  5. Site details revised at 1 of 138 sitesv28
Show 26 earlier versionsHide 26 earlier versions
  1. Eligibility criteria expanded, about 53 words
    • Site details revised at 9 of 138 sites
    • Study description shortened, about 1 word
    v27
  2. Study sites: 137 to 138v26
  3. Site details revised at 4 of 137 sitesv25
  4. Site details revised at 1 of 137 sitesv24
  5. Study sites: 136 to 137v23
  6. Study sites: 135 to 136v22
  7. Study sites: 131 to 135v21
  8. Primary completion date: Jun 2025 to Apr 2027
    • Study sites: 130 to 131
    • Study completion date: Oct 2025 to Jun 2027
    v20
  9. Study sites: 129 to 130v19
  10. Study sites: 125 to 129v18
  11. Study sites: 124 to 125v17
  12. Study sites: 120 to 124
    • Interventions: Placebo (Drug), XEN1101 (Drug), XEN1101 (Drug) to Placebo (Drug), XEN1101 (Drug)
    • Eligibility criteria expanded, about 5 words
    v16
  13. Study sites: 114 to 120v15
  14. Study sites: 111 to 114v14
  15. Study sites: 106 to 111v13
  16. Study sites: 91 to 106v12
  17. Study sites: 53 to 91v11
  18. Study sites: 46 to 53v10
  19. Eligibility criteria revised
    • Study description revised
    v9
  20. Study sites: 25 to 46v8 Show 4 more changesShow less
    • Interventions: Placebo (Drug), XEN1101 (Drug) to Placebo (Drug), XEN1101 (Drug), XEN1101 (Drug)
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 27 words
    • Study arms: 2 to 3
  21. Study sites: 17 to 25v7
  22. Study sites: 8 to 17v6
  23. Study sites: 6 to 8v5
  24. Study sites: 4 to 6v4
  25. Start date changed from estimate of Feb 2023 to Feb 14, 2023v3
  26. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2022 to Feb 2023
    • Study sites: 0 to 4
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Median percent change (MPC) in monthly (28 days) PGTCS frequency
Timeframe: Baseline through DBP (Week 12)

Secondary (1)

Proportion of subjects

Arms and interventions

XEN1101 25 mg/dayExperimental

XEN1101 25 mg/day

XEN1101 15 mg/dayExperimental

XEN1101 15 mg/day

PlaceboPlacebo comparator

Placebo

Drugs: XEN1101, Placebo

Sites

141 sites in 20 countries

United States 62, Germany 10, Portugal 7, Australia 6, United Kingdom 6, France 5, Italy 5, Poland 5, Spain 5, Argentina 4, Austria 4, Canada 4, Israel 4, Bulgaria 3, Croatia 3, Mexico 3, Belgium 2, Chile 1, Czechia 1, Netherlands 1