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

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This (DEEp OCEAN 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 DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 65
Healthy Volunteers: f
View:

• Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria:

‣ Onset of seizures at ≤8 years old

⁃ History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms

⁃ Presence of developmental plateauing or regression

⁃ History of electroencephalogram (EEG) showing generalized slow (\<2.5 Hertz \[Hz\]) spike-and-wave complexes

• Participants who are characterized as having DEE (Other) must fulfill all of the following criteria:

‣ Does not meet criteria for LGS

⁃ Onset of seizures at ≤5 years old

⁃ Presence of developmental plateauing or regression

⁃ History of multiple seizure types

⁃ History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity)

• 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 each of 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; in instances where the participant is unable to provide consent, an appropriate legal representative.

Locations
United States
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
California
The Stanford Division of Child Neurology
RECRUITING
Palo Alto
UCSF Children's Hospital
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado.
RECRUITING
Aurora
Florida
NW FL Clinical Research Group, LLC
RECRUITING
Gulf Breeze
Research Institute of Orlando LLC
RECRUITING
Orlando
Pediatric Epilepsy and Neurology Specialists
RECRUITING
Tampa
University of South Florida - 2 Tampa General Circle
RECRUITING
Tampa
Georgia
Rare Disease Research, LLC - Atlanta - RDR - PIN
COMPLETED
Atlanta
Maryland
Mid-Atlantic Epilepsy and Sleep Center
RECRUITING
Bethesda
New Jersey
Institute of Neurology and Neurosurgery at Saint Barnabas, LLC
RECRUITING
Livingston
Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave
RECRUITING
Morristown
Oregon
Oregon Health and Science University
RECRUITING
Portland
Tennessee
Le Bonheur Childrens Hospital
RECRUITING
Memphis
Texas
Child Neurology Consultants of Austin
RECRUITING
Austin
The University of Texas Medical School at Houston
RECRUITING
Houston
Washington
Multicare Health System - Mary Bridge Pediatrics
RECRUITING
Tacoma
Other Locations
Australia
Austin Hospital
RECRUITING
Heidelberg
Sydney Children's Hospital
RECRUITING
Randwick
Queensland Children's Hospital
RECRUITING
South Brisbane
France
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
RECRUITING
Bron
Hôpital Roger Salengro
RECRUITING
Lille
AP-HM- Hôpital de La Timone
RECRUITING
Marseille
AP-HP - Hôpital universitaire Robert-Debré
RECRUITING
Paris
CHU de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
Germany
Gesellschaft für Epilepsieforschung e.V.
RECRUITING
Bielefeld
Klinikum der Johann-Wolfgang Goethe-Universitat
RECRUITING
Frankfurt Am Main
Universitätsklinikum Schleswig-Holstein - Campus Kiel
RECRUITING
Kiel
Epilepsie-Zentrum Bodensee
RECRUITING
Ravensburg
Latvia
Children's Clinical University Hospital
RECRUITING
Riga
Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
RECRUITING
Belgrade
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Spain
Hospital Sant Joan de Deu - PIN
RECRUITING
Espluges De Llobregat
Hospital Ruber Internacional (Grupo Quironsalud)
RECRUITING
Madrid
Hospital Universitario Vithas Madrid La Milagrosa
RECRUITING
Madrid
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING
Málaga
Hospital Universitario de Navarra
RECRUITING
Pamplona
United Kingdom
Queen Elizabeth University Hospital - PPDS
RECRUITING
Glasgow
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
+45 36301311
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 320
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Longboard Pharmaceuticals

This content was sourced from clinicaltrials.gov