A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
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
Longboard Pharmaceuticals
320 participants
Nov 11, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria16
- 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 Criteria8
- 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.
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Interventions
LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
Participants will be administered with matching placebo orally or through G-tube/ PEG tube.
Locations(106)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06719141