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NCT06719141

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

Active, Not Recruiting
PHASE3Ages 2–65InterventionalTreatment
Longboard Pharmaceuticals
~367 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:LP352Placebo

At a glance

Recruiting sites
0 of 116 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
Measured over Baseline and up to 15 Weeks

Conditions

Developmental and Epileptic Encephalopathy

Explore related trials

Developmental and Epileptic EncephalopathyLennox-Gastaut Syndrome

NCT06719141

Where you'd take part

This study runs at 116 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AP-HM- Hôpital de La Timone

    Marseille, Franceno site contact published

  • AP-HP - Hôpital universitaire Necker-Enfants malades

    Paris, Franceno site contact published

  • AP-HP - Hôpital universitaire Robert-Debré

    Paris, Franceno site contact published

  • Arkansas Children's Hospital - Cardiology Clinic

    Little Rock, Arkansasno site contact published

  • Austin Hospital

    Heidelberg, Victoria, Australiano site contact published

  • Azienda Ospedaliera Universitaria Integrata Verona - Centro Fibrosi Cistica di Verona (CFC Verona)

    Verona, Italyno site contact published

  • Azienda Ospedaliero-Universitaria Meyer - Ospedale dei Bambini

    Florence, Tuscany, Italyno site contact published

  • Barnabas Health - Institute of Neurology and Neurosurgery

    Livingston, New Jerseyno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria:
Onset of seizures at ≤8 years old
History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms
Presence of developmental plateauing or regression
History of electroencephalogram (EEG) showing generalized slow (\<2.5 Hertz \[Hz\]) spike-and-wave complexes
Participants who are characterized as having DEE (Other) must fulfill all of the following criteria:
Does not meet criteria for LGS
Onset of seizures at ≤5 years old
Presence of developmental plateauing or regression
History of multiple seizure types
History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity)
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 each of 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; in instances where the participant is unable to provide consent, an appropriate legal representative.

Exclusion

The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS.
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 unable or unwilling to comply with any of the study requirements or timelines.

What this trial measures

  • Frequency Percent Change in Countable Motor Seizures During Treatment Compared to BaselineBaseline and up to 15 Weeks

    The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.