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LP352 for Dravet Syndrome Seizures

This study is testing a drug called LP352 to see if it can reduce seizures in children and adults with Dravet Syndrome (DS). LP352 will be given either by mouth or through a feeding tube. Some participants will receive LP352, while others will receive a placebo (an inactive substance that looks like the study drug). Researchers will compare how often seizures happen in both groups. The study is looking for people aged 2 to 65 years old who have been diagnosed with Dravet Syndrome and meet specific seizure history criteria. The main goal is to see if LP352 changes the number of motor seizures you have during treatment compared to before treatment. The current recruitment status is unclear.

Study design
This is a double-blind, randomized, placebo-controlled study involving 160 participants. This means neither you nor your doctor will know if you are receiving LP352 or the placebo.
What's involved
The study involves several phases: Screening, Titration (adjusting the dose), Maintenance, Taper (gradually reducing the dose), and Follow-Up. The total study duration is approximately 24 months.
Compensation
Not stated in the trial record.
Follow-up
There is a Taper period and a Follow-Up period after the Maintenance period, but the exact duration of follow-up is not specified.

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NCT06660394

A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

Recruiting
PHASE3Ages 2–65InterventionalTreatment
Longboard Pharmaceuticals
~104 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:LP352Placebo

At a glance

Recruiting sites
101 of 104 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

Dravet Syndrome

Explore related trials

Developmental and Epileptic Encephalopathy 6A

Where it's being run

104 sites across 66 states
France6
Spain5
California4
Florida4
Texas3
New South Wales3
Victoria3
São Paulo3

Who to contact

Email contact via H. Lundbeck A/S
[email protected]
+45 36301311
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of DS must fulfill all of the following criteria:
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

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.

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.