A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Recruiting · NCT06660394 · Interventional (participants receive a specific treatment) · Lead sponsor: Longboard Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
LP352Placebo
What this trial is about
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.
Who can take part
Age range
2 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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.
Where it is running
60 locations listed across 15 US states.
- Arkansas Children's Hospital - Cardiology Clinic - Little Rock, Arkansas, United States
- Children's Hospital Los Angeles - PIN - Los Angeles, California, United States
- David Geffen School of Medicine at UCLA - Los Angeles, California, United States
- The Stanford Division of Child Neurology - Palo Alto, California, United States
- UCSF Benioff Children's Hospitals - San Francisco - San Francisco, California, United States
- Children's Hospital Colorado. - Aurora, Colorado, United States
- Children's National Medical Center - Washington D.C., District of Columbia, United States
- NW FL Clinical Research Group, LLC - Gulf Breeze, Florida, United States
- Nicklaus Children's Hospital - PIN - Miami, Florida, United States
- Research Institute of Orlando LLC - Orlando, Florida, United States
- Pediatric Epilepsy and Neurology Specialists - Tampa, Florida, United States
- Rare Disease Research, LLC - Atlanta - RDR - PIN - Atlanta, Georgia, United States
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- Ann and Robert H Lurie Childrens Hospital of Chicago - PIN - Chicago, Illinois, United States
- Mid-Atlantic Epilepsy and Sleep Center - Bethesda - Bethesda, Maryland, United States
- Mayo Clinic Children's - PIN - Rochester, Minnesota, United States
- Institute of Neurology and Neurosurgery at Saint Barnabas, LLC - Livingston, New Jersey, United States
- Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave - Morristown, New Jersey, United States
- NYU Langone Health-NYU Comprehensive Epilepsy Center - New York, New York, United States
- Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program - Portland, Oregon, United States
- Le Bonheur Childrens Outpatient Center - PIN - Memphis, Tennessee, United States
- Child Neurology Consultants of Austin - 6811 Austin Center Blvd - Austin, Texas, United States
- Cook Children's Jane and John Justin Neurosciences Center - PIN - Fort Worth, Texas, United States
- The University of Texas Medical School at Houston - UT Gastroenterology - Houston, Texas, United States
- Multicare Health System - Mary Bridge Pediatrics - Tacoma, Washington, United States
- Hospital Universitario Vall d'Hebron - PPDS - Barcelona, Spain
- Hospital de la Santa Creu I Sant Pau - Barcelona, Spain
- Beijing Children's Hospital, Capital Medical University - PIN - Beijing, China
- Mother and Child Health Care Institute of Serbia Dr Vukan Cupic - Belgrade, Serbia
- Gesellschaft für Epilepsieforschung e.V. - Bielefeld, Germany
- Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer - Bron, France
- ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra - Coimbra, Portugal
- UZ Antwerpen - Edegem, Belgium
- Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate) - Genova, Italy
- NHS Greater Glasgow and Clyde Glasgow Clinical Research Facility-Queen Elizabeth University Hospi... - Glasgow, United Kingdom
- Universitätsklinikum Schleswig-Holstein - Campus Kiel - Kiel, Germany
- University Clinical Center Kragujevac - Kragujevac, Serbia
- ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS - Lisbon, Portugal
- University College London Hospitals (UCLH) - PPDS - London, United Kingdom
- Great Ormond Street Hospital for Children NHS Foundation Trust - London, United Kingdom
- Hospital Universitario Vithas Madrid La Milagrosa - Madrid, Spain
- Hospital Ruber Internacional (Grupo Quironsalud) - Madrid, Spain
- AP-HM- Hôpital de La Timone - Marseille, France
- Hospital Vithas Malaga - Málaga, Spain
- AP-HP - Hôpital universitaire Necker-Enfants malades - Paris, France
- AP-HP - Hôpital universitaire Robert-Debré - Paris, France
- Epilepsie-Zentrum Bodensee - Ravensburg, Germany
- CHU de Rennes - Hôpital Pontchaillou - Rennes, France
- IRCCS Ospedale Pediatrico Bambino Gesu - Roma, Italy
- CHU de Strasbourg - Hôpital de Hautepierre - Strasbourg, France
- Instituto de Psiquiatria HC FMUSP - São Paulo, Brazil
- Azienda Ospedaliera Universitaria Integrata Verona - Centro Fibrosi Cistica di Verona (CFC Verona) - Verona, Italy
- Hospital Sant Joan de Deu - PIN - Espluges de Llobregat, Barcelona, Spain
- Peking University First Hospital - Daxing Campus - Beijing, Beijing Municipality, China
- University Clinical Center of Serbia - Dr Subotica 6 - PPDS - Belgrade, Belgrade, Serbia
- University of Belgrade-Faculty of Medicine - Clinic of Neurology and Psychiatry for Children and ... - Belgrade, Beograd, Serbia
- Children's and Women's Health Centre of British Columbia-4480 Oak St - Vancouver, British Columbia, Canada
- IUHW Narita Hospital - Narita, Chiba, Japan
- Fukuoka Children's Hospital (FCH) - Fukuoka, Fukuoka, Japan
- The Second Affiliated Hospital of Guangzhou Medical University - Guangzhou, Guangdong, China
Showing 60 of 104 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →