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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Longboard Pharmaceuticals
Study ID
NCT06660394
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Dravet Syndrome

Eligibility Criteria

Sex
ALL
Age
2 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LP352 — DRUG
    LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
  • Placebo — DRUG
    Participants will be administered with matching placebo orally or through G-tube/ PEG tube

Study Details

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 Dates

First listed
Oct 28, 2024
Start date
Sep 25, 2024
Status verified
Aug 2026
Primary completion
Aug 21, 2026
Completion
Oct 2, 2026

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (25)

FacilityCityStateZIPSite coordinators
Arkansas Children's Hospital - Cardiology ClinicLittle RockArkansas72202-3500-
Children's Hospital Los Angeles - PINLos AngelesCalifornia90027-6062-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
The Stanford Division of Child NeurologyPalo AltoCalifornia94304-1510-
UCSF Benioff Children's Hospitals - San FranciscoSan FranciscoCalifornia94158-
Children's Hospital Colorado.AuroraColorado80045-7106-
Children's National Medical CenterWashington D.C.District of Columbia20010-
NW FL Clinical Research Group, LLCGulf BreezeFlorida32561-4495-
Nicklaus Children's Hospital - PINMiamiFlorida33155-3009-
Research Institute of Orlando LLCOrlandoFlorida32806-
Pediatric Epilepsy and Neurology SpecialistsTampaFlorida33609-4190-
Rare Disease Research, LLC - Atlanta - RDR - PINAtlantaGeorgia30329-
Ann and Robert H Lurie Childrens Hospital of Chicago - PINChicagoIllinois60611-
Northwestern Memorial HospitalChicagoIllinois60611-2908-
Mid-Atlantic Epilepsy and Sleep Center - BethesdaBethesdaMaryland20817-1844-
Mayo Clinic Children's - PINRochesterMinnesota55905-0001-
Institute of Neurology and Neurosurgery at Saint Barnabas, LLCLivingstonNew Jersey07039-5817-
Northeast Regional Epilepsy Group - Morristown - 310 Madison AveMorristownNew Jersey07960-
NYU Langone Health-NYU Comprehensive Epilepsy CenterNew YorkNew York10016-4852-
Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology ProgramPortlandOregon97239-3098-
Le Bonheur Childrens Outpatient Center - PINMemphisTennessee38103-2816-
Child Neurology Consultants of Austin - 6811 Austin Center BlvdAustinTexas78731-3157-
Cook Children's Jane and John Justin Neurosciences Center - PINFort WorthTexas76104-
The University of Texas Medical School at Houston - UT GastroenterologyHoustonTexas77030-1517-
Multicare Health System - Mary Bridge PediatricsTacomaWashington98405-4048-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital - Cardiology Clinic· Little Rock, ARChildren's Hospital Los Angeles - PIN· Los Angeles, CADavid Geffen School of Medicine at UCLA· Los Angeles, CAThe Stanford Division of Child Neurology· Palo Alto, CAUCSF Benioff Children's Hospitals - San Francisco· San Francisco, CAChildren's Hospital Colorado.· Aurora, CO

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