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

Launched by LONGBOARD PHARMACEUTICALS · Oct 24, 2024

Keywords

ClinConnect Summary

This clinical trial, known as the DEEp SEA Study, is looking at a new treatment called LP352 for people with Dravet Syndrome, a serious type of epilepsy that causes frequent seizures. The study will involve children and adults who have had seizures starting between 1 and 20 months of age and have experienced multiple types of seizures. To participate, individuals must have had at least four measurable seizures in the past three months while on stable doses of their current seizure medications. The trial is open to all genders and is currently recruiting participants.

Throughout the study, participants will be randomly assigned to receive either LP352 or a placebo (a treatment that looks the same but has no active medication). The trial lasts about 24 months and includes several phases: screening, a period to adjust the dosage, a maintenance phase where the participant will take the medication regularly, and a tapering period where the medication will gradually be reduced. Participants and their caregivers will need to keep track of seizures in a diary during the study. It’s important to note that certain medical conditions and medications may exclude someone from participating. If you're interested or want to learn more, please discuss it with your healthcare provider.

Gender

ALL

Eligibility 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 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.