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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Dravet Syndrome

In brief

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 adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Key facts

Study ID

NCT06660394

Run by

Longboard Pharmaceuticals

People needed

160

Starts

2024-09-25

Expected to finish

2026-10-02

Last updated by the study team

2026-07-28

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Prince of Wales Hospital — Randwick, New South Wales, Australia (enrolling)
• Sydney Children's Hospital — Randwick, New South Wales, Australia (enrolling)
• The Stanford Division of Child Neurology — Palo Alto, California, United States (enrolling)
• Arkansas Children's Hospital - PIN — Little Rock, Arkansas, United States (enrolling)
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States (enrolling)
• Nicklaus Children's Hospital - PIN — Miami, Florida, United States (enrolling)
• Children's Hospital Los Angeles - PIN — Los Angeles, California, United States (enrolling)
• Pediatric Epilepsy and Neurology Specialists — Tampa, Florida, United States (enrolling)
• Children's Hospital Colorado. — Aurora, Colorado, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• Ann and Robert H Lurie Childrens Hospital of Chicago - PIN — Chicago, Illinois, United States (enrolling)
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States (enrolling)
• Mayo Clinic - PIN — Rochester, Minnesota, United States (enrolling)
• Institute of Neurology and Neurosurgery at Saint Barnabas, LLC — Livingston, New Jersey, United States (enrolling)
• Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave — Morristown, New Jersey, United States (enrolling)
• NYU Comprehensive Epilepsy Center - BRANY - PPDS — New York, New York, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Le Bonheur Childrens Outpatient Center - PIN — Memphis, Tennessee, United States (enrolling)
• Child Neurology Consultants of Austin - 6811 Austin Center Blvd — Austin, Texas, United States (enrolling)
• Cook Children's Jane and John Justin Neurosciences Center - PIN — Fort Worth, Texas, United States (enrolling)
• The University of Texas Medical School at Houston — Houston, Texas, United States (enrolling)
• Multicare Health System - Mary Bridge Pediatrics — Tacoma, Washington, United States (enrolling)
• Children's Hospital at Westmead — Westmead, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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