The FDA has granted Priority Review to relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies, with a PDUFA target date of September 2026. Phase 2/3 trial data showed a 53% placebo-adjusted reduction in motor seizures and 66.2% increase in seizure-free days. If approved, it would be the first targeted therapy for these rare, fatal childhood conditions.
Praxis Precision Medicines has submitted new drug applications for ulixacaltamide in essential tremor and relutrigine in rare epilepsies, both granted Breakthrough Therapy Designation. The company reported $926 million in cash as of December 31, 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07509190 |
Bridging the Gap: Educating Patients on Social Determinants of Health to Improve Epilepsy Surgery Access and Outcomes |
RECRUITING | NA |
| NCT07445074 |
AI-Based Mobile Intervention on Medication Non-Adherence and Transition |
RECRUITING | NA |
| NCT05992402 |
Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery |
RECRUITING | NA |
| NCT03338478 |
Balance and Anti-Epileptic Drugs |
COMPLETED | NA |
| NCT02268578 |
Efficacy of TDCS for Treating Working Memory Dysfunction and Depression in Temporal Lobe Epilepsy |
WITHDRAWN | PHASE1 |
| NCT02084303 |
Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI |
COMPLETED | NA |
| NCT01733394 |
Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study) |
COMPLETED | PHASE4 |
| NCT01713777 |
Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Chronic-Dose 4-Period Replicate Design |
COMPLETED | PHASE4 |
| NCT00835627 |
Treatment Trial for Psychogenic Nonepileptic Seizures |
COMPLETED | PHASE4 |
| NCT00524134 |
P-glycoprotein Inhibition as Adjunct Treatment for Medically Refractory Epilepsy. |
TERMINATED | PHASE2/PHASE3 |
