Status:
RECRUITING
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Lead Sponsor:
Longboard Pharmaceuticals
Conditions:
Dravet Syndrome
Eligibility:
All Genders
2-65 years
Phase:
PHASE3
Brief Summary
This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and a...
Eligibility Criteria
Inclusion
- 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.
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.
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 2 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06660394
Start Date
September 25 2024
End Date
October 2 2026
Last Update
March 12 2026
Active Locations (93)
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1
Arkansas Children's Hospital - PIN
Little Rock, Arkansas, United States, 72202-3500
2
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-8346
3
The Stanford Division of Child Neurology
Palo Alto, California, United States, 94304-1510
4
UCSF Children's Hospital
San Francisco, California, United States, 94143-2350