Recruiting
Phase 3

LP352

Sponsor:

Longboard Pharmaceuticals

Code:

NCT06660394

Conditions

Dravet Syndrome

Eligibility Criteria

Sex: All

Age: 2 - 65

Healthy Volunteers: Not accepted

Interventions

LP352

Placebo

Study Details

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 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.

Conditions

Dravet Syndrome

Study ID

NCT06660394

Start date

Sep 25, 2024

Status verified date

Aug, 2026

Completion date

Oct 2, 2026

Anticipated

Primary completion date

Aug 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 65

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LP352

Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.

placebo comparator: Placebo

Placebo for LP352

Interventions

LP352

LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube

Placebo

Participants will be administered with matching placebo orally or through G-tube/ PEG tube

Primary outcome measure

  • Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline [ Time Frame: Baseline and up to 15 Weeks ]

Central Contacts and Locations

Central contacts

Email contact via H. Lundbeck A/S

+45 36301311HQ_Medinfo@Lundbeck.com

Locations

Arkansas Children's Hospital - Cardiology Clinic

Recruiting

Little Rock, Arkansas, United States, 72202-3500

Children's Hospital Los Angeles - PIN

Recruiting

Los Angeles, California, United States, 90027-6062

David Geffen School of Medicine at UCLA

Recruiting

Los Angeles, California, United States, 90095

The Stanford Division of Child Neurology

Recruiting

Palo Alto, California, United States, 94304-1510

Children's Hospital Colorado.

Recruiting

Aurora, Colorado, United States, 80045-7106

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

NW FL Clinical Research Group, LLC

Recruiting

Gulf Breeze, Florida, United States, 32561-4495

Nicklaus Children's Hospital - PIN

Recruiting

Miami, Florida, United States, 33155-3009

Pediatric Epilepsy and Neurology Specialists

Recruiting

Tampa, Florida, United States, 33609-4190

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611-2908

Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

Recruiting

Chicago, Illinois, United States, 60611

Mid-Atlantic Epilepsy and Sleep Center - Bethesda

Recruiting

Bethesda, Maryland, United States, 20817-1844

Mayo Clinic Children's - PIN

Recruiting

Rochester, Minnesota, United States, 55905-0001

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Recruiting

Livingston, New Jersey, United States, 07039-5817

Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

Recruiting

Morristown, New Jersey, United States, 07960

NYU Langone Health-NYU Comprehensive Epilepsy Center

Recruiting

New York, New York, United States, 10016-4852

Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program

Recruiting

Portland, Oregon, United States, 97239-3098

Le Bonheur Childrens Outpatient Center - PIN

Recruiting

Memphis, Tennessee, United States, 38103-2816

Child Neurology Consultants of Austin - 6811 Austin Center Blvd

Recruiting

Austin, Texas, United States, 78731-3157

Cook Children's Jane and John Justin Neurosciences Center - PIN

Recruiting

Fort Worth, Texas, United States, 76104

The University of Texas Medical School at Houston - UT Gastroenterology

Recruiting

Houston, Texas, United States, 77030-1517

Multicare Health System - Mary Bridge Pediatrics

Recruiting

Tacoma, Washington, United States, 98405-4048

Children's and Women's Health Centre of British Columbia-4480 Oak St

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

London Health Sciences Centre -800 Commissioners Rd E

Recruiting

London, Ontario, Canada, N6A 5W9

The Hospital for Sick Children (SickKids)

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

Longboard Pharmaceuticals

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Antiseizure medication
  • Epilepsy
  • Neurodevelopmental disorders
  • Developmental and epileptic encephalopathy
  • LP352
  • Seizures
  • DEEp SEA
  • Bexicaserin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Longboard Pharmaceuticals on 2026-08-10.