Last updated 15 days ago

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

160 patients around the world

Available in Brazil, Mexico

Longboard Pharmaceuticals

160Patients around the world

This study is for people with

Epilepsies

Dravet Syndrome

To 65 Years

All Gender

: Diagnosis of DS must fulfill all of the following criteria.
Participants with seizure onset age >1 and <20 months.
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.

: 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 has used 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.

SponsorLongboard Pharmaceuticals

Study typeInterventional

Conditions

Dravet Syndrome

Requirements

To 65 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06660394