Summary

Eligibility
for people ages 2-66 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy

Keywords

Developmental and Epileptic Encephalopathy, LP352, Bexicaserin, Seizures, DEEp OLE, Antiseizure medications, Epilepsy, Neurodevelopmental disorders, Dravet syndrome, Lennox-gastaut syndrome, Brain Diseases

Eligibility

You can join if…

Open to people ages 2-66

  • 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 Dravet Syndrome (DS), Lennox-Gastaut Syndrome (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 or legal representative must be willing and able to provide written informed consent
  • 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.

You CAN'T join if...

  • The participant is receiving exclusionary medications.
  • 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% 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 unable or unwilling to comply with any of the study requirements or timelines.

Locations

  • Site Number - USA18 not yet accepting patients
    Los Angeles California 90095 United States
  • Site Number - USA26 not yet accepting patients
    Los Angeles California 90027 United States
  • Site Number - USA02 accepting new patients
    Gulf Breeze Florida 32561 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Longboard Pharmaceuticals
ID
NCT06908226
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 324 study participants
Last Updated