A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopat… (NCT06719141) | Clinical Trial Compass
RecruitingPhase 3
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
United States320 participantsStarted 2024-11-11
Plain-language 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.
Who can participate
Age range2 Years – 65 Years
SexALL
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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 a…
What they're measuring
1
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline