LP352-303 (DEEp OLE) · LP352-303

Phase 3 open-label study aimed at evaluating the long-term efficacy and safety of treatment with LP352. Participants include children and adults experiencing seizures associated with developmental and epileptic encephalopathy.

A phase 3, open-label study investigating the long-term safety and efficacy of LP352 for the treatment of seizures in children and adults with developmental and epileptic encephalopathy.

Sponsor: Longboard Pharmaceuticals, Inc.

Phase: III

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration.
  • Diagnosis of DEE that includes DS, LGS, or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
  • Has at least one reliable and consistent parent, legal guardian, or caregiver during the study.
  • The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative must provide informed consent and the participant will need to assent (as per local regulations) before participation in the study.
  • 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.

Exclusion

  • Using exclusionary medications defined in protocol LP352-303
  • Current use of any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or containing ≥50% THC.
  • 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.
  • Is unable or unwilling to comply with any of the study requirements or timelines.