A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline — Baseline and up to 15 Weeks
The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.
Trial sites (105)
| Facility | City | Region | Status |
|---|---|---|---|
| Arkansas Children's Hospital - Cardiology Clinic | Little Rock | Arkansas | |
| Children's Hospital Los Angeles (CHLA) | Los Angeles | California | |
| University of California Los Angeles (UCLA) - David Geffen School of Medicine - Global Health Pro... | Los Angeles | California | |
| Stanford University - Stanford School of Medicine - Pulmonary and Cystic Fibrosis Center | Palo Alto | California | |
| UCSF Benioff Children's Hospitals - San Francisco | San Francisco | California | |
| Children's Hospital Colorado - Heart Institute | Aurora | Colorado | |
| Children's National Hospital - Children's National Heart Center | Washington D.C. | District of Columbia | |
| NW FL Clinical Research Group, LLC | Gulf Breeze | Florida | |
| Nicklaus Children's Hospital (Miami Children's Hospital) | Miami | Florida | |
| Research Institute of Orlando LLC | Orlando | Florida | |
| Pediatric Epilepsy & Neurology Specialists (PENS) | Tampa | Florida | |
| Rare Disease Research, LLC. (RDR) | Atlanta | Georgia | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| Northwestern University - Ann & Robert H. Lurie Children's Hospital of Chicago - Center for Cance... | Chicago | Illinois | |
| Mid-Atlantic Epilepsy and Sleep Center - Bethesda | Bethesda | Maryland | |
| Mayo Clinic - Children's Center - Rochester | Rochester | Minnesota | |
| Barnabas Health - Institute of Neurology and Neurosurgery | Livingston | New Jersey | |
| Northeast Regional Epilepsy Group - Morristown | Morristown | New Jersey | |
| NYU Langone Health-NYU Comprehensive Epilepsy Center | New York | New York | |
| Oregon Health & Science University - Blood Brain Barrier and Neuro-Oncology Program | Portland | Oregon | |
| Le Bonheur Children's Hospital - Outpatient Center | Memphis | Tennessee | |
| Child Neurology Consultants of Austin - Austin | Austin | Texas | |
| Cook Children's Jane and John Justin Neurosciences Center | Fort Worth | Texas | |
| The University of Texas Medical School at Houston - UT Gastroenterology | Houston | Texas | |
| MultiCare Health System | Tacoma | Washington | |
| Prince of Wales Hospital (POWH) | Randwick | New South Wales | |
| Sydney Children's Hospital - Randwick | Randwick | New South Wales | |
| The Children's Hospital-Westmead - Heart Centre for Children | Westmead | New South Wales | |
| Royal Brisbane and Women's Hospital (RBWH) | Brisbane | Queensland | |
| Queensland Children's Hospital (Lady Cilento Children's Hospital) | Brisbane | Queensland | |
| Austin Hospital | Heidelberg | Victoria | |
| The Alfred Hospital | Melbourne | Victoria | |
| The Royal Children's Hospital (RCH) Melbourne | Parkville | Victoria | |
| Universitair Ziekenhuis Antwerpen (UZA) | Edegem | Antwerp | |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Flemish Brabant | |
| Instituto de Neurologia de Curitiba (INC) | Curitiba | Paraná | |
| Moinhos de Vento Hospital (Hospital Moinhos de Vento) (HMV) | Porto Alegre | Rio Grande do Sul | |
| Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Instituto Do Cerebro Do Rio Grand... | Porto Alegre | Rio Grande do Sul | |
| Universidade Estadual de Campinas (UNICAMP) - Hospital das Clinicas (HC) | Campinas | São Paulo | |
| Universidade de Sao Paulo (USP)-Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto ... | Ribeirão Preto | São Paulo |
+ 65 more sites — see the full list on the official registry below.
More Longboard Pharmaceuticals trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06660394 on ClinicalTrials.gov ↗ ← All trials in Italy