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A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)

StatusEnrolling by Invitation
PhasePhase 3
Started
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Record History

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  1. Trial sites expanded: 83 → 88 locations
  2. Study sites: 81 to 83
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 1 of 3 entries
  3. Trial sites expanded: 68 → 81 locationsv7
  4. Trial sites expanded: 16 → 68 locationsv6
  5. Study sites: 33 to 16
    • Primary completion date: Nov 2027 to Nov 11, 2027
    • Study completion date: Dec 2027 to Dec 17, 2027
    • Eligibility criteria expanded, about 601 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 33 of 33 sites
    v4
  2. Site details revised at 1 of 33 sitesv3
  3. Site details revised at 2 of 33 sitesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.
Trial Details
NCT Number NCT06908226
Lead Sponsor Longboard Pharmaceuticals
Conditions
(from sponsor)		 Developmental and Epileptic Encephalopathy
Related terms Epilepsies, Myoclonic, Epilepsy, Lennox Gastaut Syndrome, Neurodevelopmental Disorders, Seizures
Enrollment 324 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov