This study, called the DEEp OCEAN Study, is for people with Developmental and Epileptic Encephalopathies (DEE), which are brain disorders that start in childhood and cause seizures. It is a double-blind, placebo-controlled study, meaning neither the participants nor the researchers know who gets the real medicine or a placebo (a fake pill). The medicine being tested is called LP352. The study has three phases: screening, titration (adjusting medication dose), and maintenance. After these, there is a taper period (slowly reducing medication) and a follow-up to check on participants. The study lasts about 24 months.
Participants need to have a history of certain types of seizures starting at a young age and should not have Dravet Syndrome, a specific genetic disorder. They must be on stable doses of 1 to 4 anti-seizure medicines and must be able to complete diaries during the study. Important things to know include:
- Duration: Approximately 24 months
- Eligibility: Must meet specific seizure history and medication criteria
- Exclusions: Certain genetic disorders, other major health problems