Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Dravet Syndrome
Led by Longboard Pharmaceuticals · Updated on 2026-05-18
160
Participants Needed
100
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of LP352 in children and adults with Dravet Syndrome, a condition characterized by seizures. This randomized, double-blind, placebo-controlled Phase 3 study aims to assess the efficacy, safety, and tolerability of LP352 in reducing seizures. The trial is sponsored by Longboard Pharmaceuticals and includes participants aged 2 to 65 years. Participants will be randomly assigned to receive either LP352 or a matching placebo, administered orally or through a feeding tube. The study includes a Screening phase, a Titration period where doses are gradually increased to the highest tolerated level, followed by a Maintenance period, then a Taper period to reduce the dose, and finally a Follow-Up phase. The entire study will last about 24 months. During the trial, participants will be closely monitored for seizure frequency and safety outcomes. Researchers will collect data on seizure counts, medication adherence, and any side effects. The primary measure is the change in the frequency of motor seizures compared to baseline over up to 15 weeks. Participants will also undergo regular visits for evaluation, and safety will be observed up to 21 weeks. The study aims to provide detailed information on how LP352 affects seizures and overall tolerability in this population.
CONDITIONS
Brief Title
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Dravet Syndrome with seizure onset age greater than 1 and less than 20 months
- History of at least one of the following seizure types: prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus
- Current occurrence of at least one countable motor seizure type: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), or focal to bilateral tonic-clonic
- Average of at least 4 countable motor seizures per month for the 3 months prior to screening
- Taking 1 to 4 antiseizure medications at a stable dose for at least 4 weeks prior to screening
- Willing and able to comply with completion of seizure diaries throughout the study
- Willing and able to provide written informed consent
You will not qualify if you...
- History of infantile or epileptic spasms
- Hospital admission for status epilepticus requiring mechanical ventilation within 3 months prior to screening
- Neurodegenerative disorder indicated by imaging or genetic testing
- Acquired lesion or injury unrelated to the primary cause that may contribute to seizures
- Receiving exclusionary medications
- Using cannabis products or cannabidiol not in approved oral forms or containing 50% or more Delta-9-tetrahydrocannabinol (THC)
- Unstable or clinically significant neurologic, psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or abnormality that may affect participation or confound results
- Unwilling to comply with study requirements or timelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 weeks
Participants receive LP352 or placebo with a titration period to reach the highest tolerated dose, followed by a maintenance period and then a taper/down titration period.
Multiple visits from Visit 2 through Visit 8 including titration and maintenance visits
Trial Site Locations
Total: 100 locations
1
Arkansas Children's Hospital - PIN
Little Rock, Arkansas, United States, 72202-3500
Actively Recruiting
2
Children's Hospital Los Angeles - PIN
Los Angeles, California, United States, 90027-6062
Actively Recruiting
3
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-3075
Actively Recruiting
4
The Stanford Division of Child Neurology
Palo Alto, California, United States, 94304-1510
Actively Recruiting
5
UCSF Children's Hospital
San Francisco, California, United States, 94143-2350
Completed
6
Children's Hospital Colorado.
Aurora, Colorado, United States, 80045-7106
Actively Recruiting
7
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
8
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States, 32561-4458
Actively Recruiting
9
Nicklaus Children's Hospital - PIN
Miami, Florida, United States, 33155-3009
Actively Recruiting
10
Research Institute of Orlando LLC
Orlando, Florida, United States, 32806-5411
Completed
11
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States, 33609-4190
Actively Recruiting
12
Rare Disease Research, LLC - Atlanta - RDR - PIN
Atlanta, Georgia, United States, 30329
Completed
13
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
Chicago, Illinois, United States, 60611
Actively Recruiting
14
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817-1844
Actively Recruiting
15
Mayo Clinic - PIN
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
16
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey, United States, 07039-5817
Actively Recruiting
17
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
Morristown, New Jersey, United States, 07960
Actively Recruiting
18
NYU Comprehensive Epilepsy Center - BRANY - PPDS
New York, New York, United States, 10016-4852
Actively Recruiting
19
Oregon Health and Science University
Portland, Oregon, United States, 97239-3011
Actively Recruiting
20
Le Bonheur Childrens Outpatient Center - PIN
Memphis, Tennessee, United States, 38103-2816
Actively Recruiting
21
Child Neurology Consultants of Austin - 6811 Austin Center Blvd
Austin, Texas, United States, 78757
Actively Recruiting
22
Cook Children's Jane and John Justin Neurosciences Center - PIN
Fort Worth, Texas, United States, 76104-2710
Actively Recruiting
23
The University of Texas Medical School at Houston
Houston, Texas, United States, 77030
Actively Recruiting
24
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington, United States, 98405
Actively Recruiting
25
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
26
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
27
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
28
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029
Actively Recruiting
29
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
30
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
31
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia, 3052
Actively Recruiting
32
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
33
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
34
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
35
Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
36
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Actively Recruiting
37
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, Brazil, 13083-888
Actively Recruiting
38
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, São Paulo, Brazil, 14051-140
Actively Recruiting
39
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
40
Instituto de Psiquiatria HC FMUSP
São Paulo, Brazil, 05403-010
Actively Recruiting
41
Children's and Women's Health Centre of British Columbia-4480 Oak St
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
42
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, Canada, N6A 5W9
Actively Recruiting
43
Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
44
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
45
Peking University First Hospital - Daxing Campus
Beijing, Beijing Municipality, China, 102627
Actively Recruiting
46
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
47
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
48
Wuhan Children's Hospital
Wuhan, Hubei, China, 430010
Actively Recruiting
49
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
50
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, China, 100045
Actively Recruiting
51
Hôpital Roger Salengro
Lille, Nord, France, 59000
Actively Recruiting
52
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, France, 69500
Actively Recruiting
53
AP-HM- Hôpital de La Timone
Marseille, France, 13386
Actively Recruiting
54
Hôpital Necker - Enfants Malades
Paris, France, 75015
Actively Recruiting
55
AP-HP - Hôpital universitaire Robert-Debré
Paris, France, 75019
Actively Recruiting
56
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35203
Actively Recruiting
57
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
58
Centre Hospitalier Universitaire de Toulouse
Toulouse, France, 31330
Actively Recruiting
59
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, Germany, 60596
Actively Recruiting
60
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
61
Gesellschaft für Epilepsieforschung e.V.
Bielefeld, Germany, 33617
Actively Recruiting
62
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
63
Epilepsie-Zentrum Bodensee
Ravensburg, Germany, 88214
Actively Recruiting
64
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio, Italy, 00168
Actively Recruiting
65
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, Italy, 27100
Actively Recruiting
66
Azienda Ospedaliero Universitaria A Meyer (Duplicate)
Florence, Tuscany, Italy, 50139
Actively Recruiting
67
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, Italy, 37126
Actively Recruiting
68
Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)
Genova, Italy, 16147
Actively Recruiting
69
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma, Italy, 00165
Actively Recruiting
70
IUHW Narita Hospital
Narita, Chiba, Japan, 286-8520
Actively Recruiting
71
Fukuoka Children's Hospital
Fukuoka, Fukuoka, Japan, 813-0017
Actively Recruiting
72
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan, 060-8648
Actively Recruiting
73
National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, Niigata, Japan, 950-2074
Actively Recruiting
74
Okayama University Hospital
Okayama, Okayama-ken, Japan, 700-8558
Actively Recruiting
75
Osaka City General Hospital
Osaka-Shi Miyakojima-Ku, Osaka, Japan, 534-0021
Actively Recruiting
76
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama, Japan, 330-8777
Actively Recruiting
77
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, Japan, 420-0953
Actively Recruiting
78
Dokkyo Medical University Hospital
Mibu-Machi, Shimotsugagun, Tochigi, Japan, 321-0293
Actively Recruiting
79
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, Japan, 187-8502
Actively Recruiting
80
Children's Clinical University Hospital
Riga, Rīgas Apriņķis, Latvia, LV-1004
Actively Recruiting
81
Instituto Nacional de Pediatría
Mexico City, Mexico, 4530
Actively Recruiting
82
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, Portugal, 3000-602
Actively Recruiting
83
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, Portugal, 1649-035
Actively Recruiting
84
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto, Portugal, 4050-651
Actively Recruiting
85
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
Belgrade, Belgrade, Serbia, 11000
Actively Recruiting
86
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, Serbia, 11000
Actively Recruiting
87
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, Serbia, 11000
Actively Recruiting
88
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
89
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
90
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain, 29010
Actively Recruiting
91
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
92
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Actively Recruiting
93
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain, 8041
Actively Recruiting
94
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, Spain, 28010
Actively Recruiting
95
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, Spain, 28034
Actively Recruiting
96
Hospital Vithas Malaga
Málaga, Spain, 29016
Actively Recruiting
97
Royal Victoria Infirmary
Newcastle upon Tyne, Northamptonshire, United Kingdom, NE1 4LP
Actively Recruiting
98
Queen Elizabeth University Hospital - PPDS
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
99
University College London Hospitals (UCLH) - PPDS
London, United Kingdom, NW1 2PG
Actively Recruiting
100
Great Ormond Street Hospital - PPDS
London, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
E
Email contact via H. Lundbeck A/S
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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