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 Developmental and Epileptic Encephalopathies
Led by Longboard Pharmaceuticals · Updated on 2026-05-18
320
Participants Needed
110
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug LP352 in children and adults who have developmental and epileptic encephalopathies (DEE), including Lennox-Gastaut Syndrome (LGS) and other types of DEE. This phase 3, randomized, double-blind, placebo-controlled, multicenter study aims to assess the effectiveness, safety, and tolerability of LP352 for reducing seizures in this population. The study is sponsored by Longboard Pharmaceuticals and will last about 24 months. Participants will be randomly assigned to receive either LP352 or a matching placebo. LP352 is given orally or through a feeding tube (G-tube or PEG tube). The study includes several phases: a Screening phase, a Titration period where the dose is gradually increased to the highest tolerated level, a Maintenance period to continue treatment, followed by a Taper period to reduce the dosage and a final Follow-Up phase. During the trial, participants will be monitored for seizure frequency, safety, and tolerability. Seizure counts will be recorded to measure change from baseline over about 15 weeks. Participants and caregivers will complete diaries to track seizures and treatment adherence. Safety assessments will be conducted up to 21 weeks. The total participation time covers screening through follow-up, lasting roughly two years.
CONDITIONS
Brief Title
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with Lennox-Gastaut Syndrome (LGS) must have seizure onset at age 8 years or younger
- LGS participants must have tonic/tonic-atonic seizures plus at least one other specified seizure type
- LGS participants must show developmental plateauing or regression
- LGS participants must have EEG showing generalized slow spike-and-wave complexes
- Participants with other DEE must not meet LGS criteria
- Other DEE participants must have seizure onset at age 5 years or younger
- Other DEE participants must have developmental plateauing or regression
- Other DEE participants must have history of multiple seizure types
- Other DEE participants must have EEG showing diffuse or multifocal slowing
- Participants must currently have at least one countable motor seizure type
- Participants must have averaged at least 4 countable motor seizures per month for the past 3 months
- Participants must be taking 1 to 4 antiseizure medications at stable doses for at least 4 weeks
- Participants or caregivers must be able and willing to complete seizure diaries
- Participants must be willing and able to provide written informed consent or have a legal representative
You will not qualify if you...
- Diagnosis of Dravet Syndrome or mutation in SCN1A gene consistent with Dravet Syndrome
- Hospitalization for status epilepticus requiring mechanical ventilation within 3 months prior to screening
- Presence of neurodegenerative disorder shown by MRI or genetic testing
- Acquired brain lesion or injury unrelated to primary epilepsy cause
- Use of exclusionary medications
- Current use of cannabis or cannabidiol products not meeting specified criteria
- Unstable or clinically significant neurologic, psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease that may affect participation
- Inability or unwillingness 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 15 weeks
Participants receive LP352 or placebo through oral or G-tube/PEG tube administration, including titration, maintenance, and tapering periods.
Approximately 8 visits including titration, maintenance, and tapering periods
Duration - Up to 6 weeks after treatment
Participants are monitored for safety and tolerability after treatment completion.
Follow-up visits as required to monitor safety
Trial Site Locations
Total: 110 locations
1
Arkansas Children's Hospital - PIN
Little Rock, Arkansas, United States, 72202
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
Actively Recruiting
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, 20010-2916
Actively Recruiting
8
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States, 32561-4458
Actively Recruiting
9
University of Miami - 1120 NW 14th St
Miami, Florida, United States, 33136-2107
Actively Recruiting
10
Nicklaus Children's Hospital - PIN
Miami, Florida, United States, 33155-3009
Actively Recruiting
11
Research Institute of Orlando LLC
Orlando, Florida, United States, 32806-5411
Completed
12
University of South Florida - 2 Tampa General Circle
Tampa, Florida, United States, 33606
Actively Recruiting
13
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States, 33609-4190
Actively Recruiting
14
Children's Healthcare of Atlanta - Center for Advanced Pediatrics - PIN
Atlanta, Georgia, United States, 30329
Actively Recruiting
15
Rare Disease Research, LLC - Atlanta - RDR - PIN
Atlanta, Georgia, United States, 30329
Completed
16
Consultants In Epilepsy and Neurology PLLC
Boise, Idaho, United States, 83702-5029
Actively Recruiting
17
Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
Chicago, Illinois, United States, 60611
Actively Recruiting
18
University of Iowa Hospitals & Clinics - (CRS)
Iowa City, Iowa, United States, 52242-1009
Actively Recruiting
19
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817-1844
Actively Recruiting
20
Massachusetts General Hospital - 175 Cambridge St
Boston, Massachusetts, United States, 02114
Actively Recruiting
21
Mayo Clinic - PIN
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
22
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
Livingston, New Jersey, United States, 07039-5817
Actively Recruiting
23
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
Morristown, New Jersey, United States, 07960
Actively Recruiting
24
NYU Comprehensive Epilepsy Center - BRANY - PPDS
New York, New York, United States, 10016-4852
Actively Recruiting
25
Oregon Health and Science University
Portland, Oregon, United States, 97239-3011
Actively Recruiting
26
Le Bonheur Childrens Outpatient Center - PIN
Memphis, Tennessee, United States, 38103-2816
Actively Recruiting
27
Child Neurology Consultants of Austin - 6811 Austin Center Blvd
Austin, Texas, United States, 78757
Actively Recruiting
28
Cook Children's Jane and John Justin Neurosciences Center - PIN
Fort Worth, Texas, United States, 76104-2710
Actively Recruiting
29
The University of Texas Medical School at Houston
Houston, Texas, United States, 77030
Actively Recruiting
30
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington, United States, 98405-4048
Actively Recruiting
31
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
32
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
33
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
34
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4006
Actively Recruiting
35
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
36
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
37
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia, 3052
Actively Recruiting
38
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
39
UZ Antwerpen
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
40
UZ Leuven - PPDS
Leuven, Belgium, 3000
Actively Recruiting
41
Instituto de Neurologia de Curitiba (INC)
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
42
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Actively Recruiting
43
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, São Paulo, Brazil, 14051-140
Actively Recruiting
44
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
45
Instituto de Psiquiatria HC FMUSP
São Paulo, Brazil, 05403-010
Actively Recruiting
46
Children's and Women's Health Centre of British Columbia-4480 Oak St
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
47
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, Canada, N6A 5W9
Actively Recruiting
48
Peking University First Hospital - Daxing Campus
Beijing, Beijing Municipality, China, 102627
Actively Recruiting
49
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
50
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
51
Wuhan Children's Hospital
Wuhan, Hubei, China, 430010
Actively Recruiting
52
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
53
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, China, 100045
Actively Recruiting
54
Hôpital Roger Salengro
Lille, Nord, France, 59000
Actively Recruiting
55
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, France, 69500
Actively Recruiting
56
AP-HM- Hôpital de La Timone
Marseille, France, 13386
Actively Recruiting
57
Hôpital Necker - Enfants Malades
Paris, France, 75015
Actively Recruiting
58
AP-HP - Hôpital universitaire Robert-Debré
Paris, France, 75019
Actively Recruiting
59
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35203
Actively Recruiting
60
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
61
Centre Hospitalier Universitaire de Toulouse
Toulouse, France, 31330
Actively Recruiting
62
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, Germany, 60596
Actively Recruiting
63
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
64
Epilepsiezentrum Kleinwachau gemeinnützige Gmbh
Radeberg, Saxony, Germany, 01454
Completed
65
Gesellschaft für Epilepsieforschung e.V.
Bielefeld, Germany, 33617
Actively Recruiting
66
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
67
Epilepsie-Zentrum Bodensee
Ravensburg, Germany, 88214
Actively Recruiting
68
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome, Lazio, Italy, 00168
Actively Recruiting
69
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy, 20133
Actively Recruiting
70
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Lombardy, Italy, 27100
Actively Recruiting
71
Azienda Ospedaliero Universitaria A Meyer (Duplicate)
Florence, Tuscany, Italy, 50139
Actively Recruiting
72
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, Italy, 37126
Actively Recruiting
73
Istituto G Gaslini Ospedale Pediatrico IRCCS (Duplicate)
Genova, Italy, 16147
Actively Recruiting
74
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma, Italy, 00165
Actively Recruiting
75
IUHW Narita Hospital
Narita, Chiba, Japan, 286-8520
Actively Recruiting
76
Fukuoka Children's Hospital
Fukuoka, Fukuoka, Japan, 813-0017
Actively Recruiting
77
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan, 060-8648
Actively Recruiting
78
National Hospital Organization Nishi-Niigata Chuo National Hospital
Niigata, Niigata, Japan, 950-2074
Actively Recruiting
79
Okayama University Hospital
Okayama, Okayama-ken, Japan, 700-8558
Actively Recruiting
80
Osaka City General Hospital
Osaka-Shi Miyakojima-Ku, Osaka, Japan, 534-0021
Actively Recruiting
81
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama, Japan, 330-8777
Actively Recruiting
82
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, Japan, 420-0953
Actively Recruiting
83
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, Japan, 187-8502
Actively Recruiting
84
Dokkyo Medical University Hospital
Mibu-Machi, Shimotsugagun, Japan, 321-0293
Actively Recruiting
85
Children's Clinical University Hospital
Riga, Rīgas Apriņķis, Latvia, LV-1004
Actively Recruiting
86
Universitair Medisch Centrum Utrecht - PPDS
Utrecht, Netherlands, 3584 CX
Actively Recruiting
87
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, Portugal, 3000-602
Actively Recruiting
88
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, Portugal, 1649-035
Actively Recruiting
89
ULS de Santo António, EPE - Centro Materno Infantil Norte
Porto, Portugal, 4050-651
Actively Recruiting
90
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
Belgrade, Belgrade, Serbia, 11000
Actively Recruiting
91
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, Serbia, 11000
Actively Recruiting
92
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, Serbia, 190133
Actively Recruiting
93
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
94
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
95
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Málaga, Spain, 29010
Actively Recruiting
96
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
97
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Actively Recruiting
98
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain, 8041
Actively Recruiting
99
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, Spain, 28009
Actively Recruiting
100
Hospital Universitario Vithas Madrid La Milagrosa
Madrid, Spain, 28010
Actively Recruiting
101
Hospital Ruber Internacional (Grupo Quironsalud)
Madrid, Spain, 28034
Actively Recruiting
102
Hospital Vithas Malaga
Málaga, Spain, 29016
Actively Recruiting
103
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Actively Recruiting
104
Royal Victoria Infirmary
Newcastle upon Tyne, Northamptonshire, United Kingdom, NE1 4LP
Actively Recruiting
105
Noah's Ark Children's Hospital for Wales - PIN
Cardiff, South Glamorgan, United Kingdom, CF14 4XW
Actively Recruiting
106
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
107
Queen Elizabeth University Hospital - PPDS
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
108
University College London Hospitals (UCLH) - PPDS
London, United Kingdom, NW1 2PG
Actively Recruiting
109
Great Ormond Street Hospital - PPDS
London, United Kingdom, WC1N 3JH
Actively Recruiting
110
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
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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