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Набира участници Фаза 3 NCT06719141

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Developmental and Epileptic Encephalopathy

Спонсор: Longboard Pharmaceuticals

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * 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. Exclusion Criteria: * The participant has a diagnosis of Dravet Syndrome (DS) or has a mutation of the Sodium channel protein type 1 subunit alpha (SCN1A) gene consistent with DS. * 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 unable or unwilling to comply with any of the study requirements or timelines.
Места на провеждане 17
Австралия (1)
Prince of Wales Hospital
Randwick , New South Wales
Белгия (1)
UZ Antwerpen
Edegem , Antwerpen
Бразилия (1)
Instituto de Neurologia de Curitiba (INC)
Curitiba , Paraná
Канада (1)
Children's and Women's Health Centre of British Columbia-4480 Oak St
Vancouver , British Columbia
Китай (1)
Peking University First Hospital - Daxing Campus
Beijing , Beijing Municipality
Франция (1)
Hôpital Roger Salengro
Lille , Nord
Германия (1)
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main , Hesse
Holy See (1)
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Roma
Италия (1)
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome , Lazio
Япония (1)
IUHW Narita Hospital
Narita , Chiba
Latvia (1)
Children's Clinical University Hospital
Riga
Нидерландия (1)
Universitair Medisch Centrum Utrecht - PPDS
Utrecht
Португалия (1)
ULS de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra
Сърбия (1)
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
Belgrade , Belgrade
Испания (1)
Hospital Sant Joan de Deu - PIN
Espluges de Llobregat , Barcelona
Великобритания (1)
Queen Elizabeth University Hospital - PPDS
Glasgow , Glasgow City
САЩ (1)
Arkansas Children's Hospital - PIN
Little Rock , Arkansas
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
65 Years
Здрави доброволци
Не
Начална дата
11.11.2024
Крайна дата
30.11.2026
Регистрационен номер
NCT06719141
Източник
anzctr
Запитване за медицински туризъм

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