A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-65
SponsorLongboard Pharmaceuticals
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LP352
- Placebo
Treatment groups
320 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov