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Lundbeck

Lundbeck Trial on the
Safety and Efficacy of Bexicaserin

Bexicaserin

Recent results from an early-stage study show that patients with rare genetic epilepsies saw a steady, long-term drop in their physical seizures for up to two years while taking a new medicine called bexicaserin. The drug was generally well-tolerated and safe for the participants, which is great news. Because these results are so promising, researchers are now moving forward with a much larger study, called DEEp.1, to learn even more.

Bexicaserin achieved an overall median seizure reduction of 59.3 percent in countable motor seizures over a 12-month open-label extension (OLE) treatment period. The treatment with bexicaserin demonstrated favorable safety and tolerability, with majority of participants completing the full 12 months OLE period.

Bexicaserin is an oral medication being studied for people ages two and older with rare genetic epilepsies. It is designed to be very precise, targeting only the specific brain receptors that help control seizures while avoiding the ones that often cause unwanted side effects. The FDA has already fast-tracked its review because the early results are so promising. In a recent study of 52 people who were still having frequent seizures despite taking their regular medications, bexicaserin was tested to see if it could provide the extra control these families need.

Clinical Trial - Bexicaserin Study 

  • Drug Candidate: Bexicaserin
  • Clinical Sponsor: Lundbeck (previously Longboard)
  • Trial Name: DEEp Ocean
  • Gene Eligibility: All GRI Disorders (GRIN, GRIA, GRIK, and GRID)
  • Age Eligibility: 2 to 65 years
  • Epilepsy Requirement: Yes. Minimum of 4 countable seizures per month.
  • Will patients on placebo get access to the drug candidate? Yes. Patients who receive the placebo will transition to receiving active Bexicaserin once the first 17 weeks of the study are finished.
  • Sites Currently Open (Recruiting): US: (Arkansas, California, Colorado, Florida, Georgia, Idaho, Iowa, Maryland, Massachusetts, Minnesota, New Jersey, Oregon, Tennessee, Texas, Washington. Europe (sites in France, Germany, Italy, Latvia, Netherlands, Portugal, Serbia, Spain, UK), Asia-Pacific (sites in Australia, China).
  • To Learn More: To learn more about the DEEp Ocean study, you can visit the study-specific website https://deepdeestudy.com/ and https://clinicaltrials.gov/study/NCT06719141