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 States, Australia, Belgium320 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 range
2 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline