Effectiveness data due soon from large trial of LGS seizure treatment
Late-stage global study testing whether oral therapy can cut their frequency
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Researchers are testing the effectiveness of an oral therapy candidate in reducing seizure frequency in people with LGS and other epilepsies. (Photo from iStock)
The initial results from a large, late-stage clinical trial testing an oral seizure treatment for people with Lennox-Gastaut syndrome (LGS) and other epileptic conditions are expected by the end of this year or early next year.
That’s according to new updates from Lundbeck, a pharmaceutical company specializing in treating brain diseases, on a Phase 3 trial, dubbed DEEp OCEAN (NCT06719141), that’s testing the therapy for use in LGS and other developmental and epileptic encephalopathies (DEEs). The trial’s main goal is to assess the effectiveness of Lundbeck’s bexicaserin in reducing seizure frequency in children and adults with these conditions.
Lundbeck announced that the trial is now fully enrolled and that investigators have finished randomization, or assigning participants to the different treatment groups. Further, the developer stated in a company press release, “headline results are expected at the end of … 2026 or [in the beginning of] 2027.”
“The completion of randomization in DEEp OCEAN is an important milestone for the bexicaserin pivotal program, made possible by the commitment of patients, families, investigators, and advocacy communities,” said Johan Luthman, PhD, Lundbeck’s executive vice president and head of research and development. Per Lundbeck, participants completing the trial will be eligible to enroll in its open-label extension phase.
LGS is a form of epilepsy characterized by developmental delays and multiple types of seizures that begin during childhood. These seizures are caused by uncontrolled bursts of electrical activity in the brain.
People with LGS usually respond poorly to available medications, and treatment often requires a combination of multiple drugs, data have shown.
DEEp OCEAN study testing bexicaserin in children, adults
Bexicaserin, previously known as LP352, is an oral therapy that binds to a receptor activated by the brain chemical messenger serotonin. This enhances inhibitory signals, thus reducing excessive nerve activity that contributes to seizures.
In an earlier clinical trial that enrolled adolescents and adults with LGS and other DEEs, bexicaserin significantly reduced the frequency of seizures compared with a placebo. Among participants with LGS in that Phase 1b/2a study, dubbed PACIFIC (NCT05364021), bexicaserin reduced motor seizure frequency by one-third. Further, that reduction was maintained for as long as one year in the trial’s open-label extension (NCT05626634).
After completing the PACIFIC trial and its extension, participants could enter an expanded access program (NCT06149663) that allowed continued use of bexicaserin. Those results indicated that reductions in seizure frequency were maintained for up to two years after the start of treatment.
Now, the DEEp OCEAN study has enrolled 292 participants with LGS and other DEEs, ranging in age from 2 to 65. Each was randomly assigned to receive bexicaserin or a placebo, beginning with a three-week dose-adjustment period to determine the highest tolerated dose. That’s followed by a 12-week, or about three-month, maintenance period at the selected dose.
The study’s main goal is to assess changes in the frequency of motor seizures after 15 weeks. Secondary outcomes include bexicaserin’s safety and tolerability, as well as the proportion of patients achieving at least a 50% reduction in motor seizures. After completing the trial, eligible participants may enroll in a one-year open-label extension, in which all will receive bexicaserin.
No seizure treatment is approved for all epileptic conditions
According to Ingrid Scheffer, PhD, the study’s lead investigator, “the DEEp OCEAN trial represents a comprehensive pivotal program in DEEs, with the most diverse DEE population studied to date.”
It’s designed to capture the diversity of DEEs, which include many different genetic causes and clinical presentations.
The company noted that there are no antiseizure medications now available that are approved across all DEE subtypes, “leaving many patients without suitable treatment options,” per the release.
The DEEp OCEAN trial represents a comprehensive pivotal program in [epileptic conditions, which include LGS], with the most diverse … population studied to date.
Scheffer added that, “by including a broad range of DEE syndromes and more than 60 different genetic DEEs, this study is designed to reflect the real-world heterogeneity of these devastating conditions.”
Bexicaserin has received breakthrough therapy, orphan drug, and rare pediatric disease designations for DEEs from the U.S. Food and Drug Administration. These programs are intended to support faster development and review of therapies for serious or rare conditions.
Alongside DEEp OCEAN, Lundbeck is also evaluating bexicaserin in the Phase 3 trial DEEp SEA (NCT06660394), which is testing the therapy in people with Dravet syndrome, another severe type of DEE. Enrollment is expected to finish within the coming months, the company stated.
