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A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 21, 2026 → Dec 31, 2026
Enrollment reduced 35% 160 → 104 participants
See other at-risk trials from Longboard Pharmaceuticals

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary completion pushed from Aug 21, 2026 to Dec 31, 2026
    • Study completion pushed from Oct 2, 2026 to Dec 31, 2026
    • Enrollment target: estimated 104 to confirmed 96
    • Study sites: 104 to 105
    • Eligibility criteria expanded, about 16 words
  2. Enrollment reduced: 160 → 104 participants
    • Study sites: 102 to 104
    v18
  3. Study sites: 101 to 102v17
  4. Study sites: 100 to 101v16
  5. Trial sites expanded: 97 → 100 locationsv15
  6. Trial sites expanded: 93 → 97 locationsv14
  7. Study sites: 89 to 93v13
  8. Study sites: 77 to 89
    • Eligibility criteria expanded, about 1 word
    v12
  9. Study sites: 67 to 77v11
  10. Study sites: 63 to 67v10
  11. Study sites: 48 to 63v9
  12. Study sites: 92 to 48
    • Primary completion date: Sep 2026 to Aug 21, 2026
    • Study completion date: Oct 2026 to Oct 2, 2026
    • Start date: Oct 2, 2024 to Sep 25, 2024
    v8
  13. Site details revised at 21 of 92 sitesv7
  14. Site details revised at 5 of 92 sitesv6
  15. Site details revised at 1 of 92 sitesv5
  16. Site details revised at 2 of 92 sitesv4
  17. Study sites: 33 to 92v3
  18. Study sites: 7 to 33v2
  19. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.
Trial Details
NCT Number NCT06660394
Lead Sponsor Longboard Pharmaceuticals
Conditions
(from sponsor)		 Dravet Syndrome
Related terms Epilepsies, Myoclonic, Epilepsy, Neurodevelopmental Disorders, Seizures
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov