LP352-302 (DEEp SEA) · LP352-302

Multicenter phase 3 investigation to study the efficacy, safety, and tolerability of LP352 in pediatric and adult patients with Dravet syndrome. The study focuses on seizure management using a randomized design against placebo.

A phase 3, multicenter, randomized, double-blind, placebo-controlled study investigating the efficacy, safety, and tolerability of LP352 for the treatment of seizures in children and adults with Dravet syndrome. EU CT: 2024-514937-39-0.

Sponsor: LONGBOARD

Phase: III

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • * Diagnosis of DS must fulfill all of the following criteria:
  • 1. Participants with seizure onset age \>1 and \<20 months
  • 2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus
  • * The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic
  • * The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening.
  • * The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.
  • * The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
  • * The participant must be willing and able to provide written informed consent.

Exclusion

  • * The participant has a history of infantile/epileptic spasms.
  • * The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.
  • * The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.
  • * The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.
  • * The participant is receiving exclusionary medications.
  • * The participant is currently using any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).
  • * The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
  • * The participant is unwilling to comply with any of the study requirements or timelines.