Investigating LP352 for treating seizures in children and adults with developmental and epileptic encephalopathy
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
PHASE3 · Longboard Pharmaceuticals · NCT06908226
This study is testing a new medication called LP352 to see if it can help control seizures and improve the well-being of children and adults with developmental and epileptic encephalopathy who have already been part of earlier studies.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 2 Years to 66 Years |
| Sex | All |
| Sponsor | Longboard Pharmaceuticals (industry) |
| Locations | 33 sites (Little Rock, Arkansas and 32 other locations) |
| Trial ID | NCT06908226 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study aims to evaluate the long-term safety, efficacy, tolerability, and pharmacokinetics of LP352 in patients with developmental and epileptic encephalopathy (DEE) who have previously participated in studies LP352-301 or LP352-302. The study includes several phases: Screening, Titration, Maintenance, Taper, and Follow-Up, spanning approximately 14 months. Participants will be monitored for their response to LP352, focusing on seizure control and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are children and adults with a diagnosis of DEE, including Dravet Syndrome or Lennox-Gastaut Syndrome, who have completed prior LP352 studies.
Not a fit: Patients currently using exclusionary medications or certain cannabis products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing seizures in patients with DEE.
How similar studies have performed: Other studies have explored treatments for DEE, but the specific approach with LP352 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Little Rock, Arkansas and 32 other locations
- Site Number - USA19 — Little Rock, Arkansas, United States (NOT_YET_RECRUITING)
- Site Number - USA29 — La Jolla, California, United States (NOT_YET_RECRUITING)
- Site Number - USA26 — Los Angeles, California, United States (NOT_YET_RECRUITING)
- Site Number - USA18 — Los Angeles, California, United States (NOT_YET_RECRUITING)
- Site Number - USA24 — Palo Alto, California, United States (NOT_YET_RECRUITING)
- Site Number - USA28 — San Francisco, California, United States (NOT_YET_RECRUITING)
- Site Number - USA17 — Aurora, Colorado, United States (NOT_YET_RECRUITING)
- Site Number - USA02 — Gulf Breeze, Florida, United States (RECRUITING)
- Site Number - USA37 — Miami, Florida, United States (NOT_YET_RECRUITING)
- Site Number - USA05 — Orlando, Florida, United States (RECRUITING)
- Site Number - USA11 — Tampa, Florida, United States (NOT_YET_RECRUITING)
- Site Number - USA09 — Atlanta, Georgia, United States (NOT_YET_RECRUITING)
- Site Number - USA38 — Chicago, Illinois, United States (NOT_YET_RECRUITING)
- Site Number - USA07 — Bethesda, Maryland, United States (RECRUITING)
- Site Number - USA15 — Rochester, Minnesota, United States (NOT_YET_RECRUITING)
- Site Number - USA10 — Livingston, New Jersey, United States (RECRUITING)
- Site Number - USA36 — Morristown, New Jersey, United States (NOT_YET_RECRUITING)
- Site Number - USA32 — New York, New York, United States (NOT_YET_RECRUITING)
- Site Number - USA14 — Cincinnati, Ohio, United States (NOT_YET_RECRUITING)
- Site Number - USA39 — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
- Site Number - USA35 — Columbus, Ohio, United States (NOT_YET_RECRUITING)
- Site Number - USA33 — Portland, Oregon, United States (NOT_YET_RECRUITING)
- Site Number - USA22 — Charleston, South Carolina, United States (NOT_YET_RECRUITING)
- Site Number - USA34 — Memphis, Tennessee, United States (NOT_YET_RECRUITING)
- Site Number - USA31 — Fort Worth, Texas, United States (NOT_YET_RECRUITING)
- Site Number - USA25 — Houston, Texas, United States (NOT_YET_RECRUITING)
- Site Number - USA03 — Tacoma, Washington, United States (NOT_YET_RECRUITING)
- Site Number - AUS07 — Randwick, New South Wales, Australia (NOT_YET_RECRUITING)
- Site Number - AUS08 — Randwick, New South Wales, Australia (NOT_YET_RECRUITING)
- Site Number - AUS04 — Herston, Queensland, Australia (NOT_YET_RECRUITING)
- Site Number - AUS05 — South Brisbane, Queensland, Australia (NOT_YET_RECRUITING)
- Site Number - AUS02 — Heidelberg, Victoria, Australia (NOT_YET_RECRUITING)
- Site Number - AUS03 — Melbourne, Victoria, Australia (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Longboard Study Contact
- Email: clinicalstudies@longboardpharma.com
- Phone: 858-999-8858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Developmental and Epileptic Encephalopathy, LP352, Bexicaserin, Seizures, DEEp OLE, Antiseizure medications, Epilepsy, Neurodevelopmental disorders