Participating in clinical trials is an important way to help accelerate therapeutic development. Find more information about ongoing studies below.
SCN8A Clinical Trials
Embold Study
Praxis Precision Medicines: PRAX-562
The Phase 3 EMBOLD study evaluates the safety and effectiveness of relutrigine (PRAX-562) in reducing seizures in individuals with SCN8A- and SCN2A-related developmental and epileptic encephalopathies.
The clinical trial evaluating Relutrigine (PRAX-562) in individuals with SCN2A- and SCN8A-related developmental and epileptic encephalopathies (DEEs) has been completed, and Praxis Precision Medicines has submitted the results to the U.S. Food and Drug Administration (FDA) as part of an application for approval. The application is currently under FDA review, with a decision expected by December 27, 2026.
Relutrigine remains investigational and is not currently approved by the FDA.
To learn more about this study, you or your doctor may contact the study research staff:
Head of Pharmacovigilance
617-300-8460
clinicaltrials@praxismedicines.com
ClinicalTrials.gov identifier (NCT number): NCT05818553
DEEp Ocean Study
Lundbeck: LP352-301
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 Developmental and Epileptic Encephalopathies (DEE).
Enrollment is complete in the Phase 3 DEEp OCEAN clinical trial evaluating bexicaserin for the treatment of seizures in children and adults with developmental and epileptic encephalopathies (DEEs), including individuals with SCN8A-related disorders. More than 350 participants ages 2–65 are enrolled in the global study. Participants will continue through the trial’s treatment period, with eligible participants able to enter an open-label extension study.
Bexicaserin remains investigational and is not currently approved by the FDA.
To learn more about this study, you or your doctor may contact the study research staff:
Longboard Study Contact
858-999-8858
clinicalstudies@longboardpharma.com
ClinicalTrials.gov identifier (NCT number): NCT06719141
Kayak Study
Neurocrine Biosciences:
NBI-921352
The Kayak Study has been discontinued.
PRAX-562 Epilepsy Program Updates
Embold Study Update: April 2023
From Data to Development
A Deeper Look at PRAX-562 and Your Role in its Progress
Embold Study Update: September 2022
Clinical Trial Phases
Phase 1
Researchers test a drug or treatment in a small group of people to learn about safety and identify side effects.
Phase 2
The new drug or treatment is given to a larger group of people to determine its effectiveness and further study its safety.
Phase 3
The new drug or treatment is tested in large groups to confirm effectiveness, monitor side effects, compare with existing treatments, and ensure safe use.
Phase 4
Post-approval, researchers track its safety in the general population to gain more information about a drug or treatment’s benefits and optimal use.
Clinical Trial Glossary
Words and terms that may be helpful to know as you explore clinical trial participation.