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Investigating LP352 for treating seizures in Dravet Syndrome

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Dravet Syndrome

Phase 3 Interventional Longboard Pharmaceuticals · NCT06660394

This study is testing a new medication called LP352 to see if it can help children and adults with Dravet Syndrome who have frequent seizures, even with current treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment160 (estimated)
Ages2 Years to 65 Years
SexAll
SponsorLongboard Pharmaceuticals Industry-sponsored
Locations97 sites (Little Rock, Arkansas and 96 other locations)
Trial IDNCT06660394 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, placebo-controlled, multicenter study aimed at evaluating the efficacy, safety, and tolerability of LP352 in children and adults diagnosed with Dravet Syndrome. The study involves several phases including screening, titration, maintenance, taper, and follow-up, with participants being assigned to receive either LP352 or a placebo. The total duration of the study is approximately 24 months, focusing on participants who experience frequent seizures despite current treatments.

Who should consider this trial

Good fit: Ideal candidates are children and adults diagnosed with Dravet Syndrome who experience frequent seizures and have been on stable antiseizure medications.

Not a fit: Patients who do not have Dravet Syndrome or those who are not experiencing frequent seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for managing seizures in patients with Dravet Syndrome.

How similar studies have performed: Other studies investigating similar antiseizure medications have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Little Rock, Arkansas and 96 other locations

+47 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Dravet SyndromeAntiseizure medicationEpilepsyNeurodevelopmental disordersDevelopmental and epileptic encephalopathyLP352SeizuresDEEp SEA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.