What the trial was testing
The trial enrolled 262 patients with epilepsy. The study was sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Children on the higher dose had 75% fewer convulsive seizures—dropping from 21 per month to fewer than 5.
Lancet (London, England) · 2019 · NCT02682927
These findings — that kids on the higher dose had three-quarters fewer convulsive seizures per month — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 262 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with epilepsy, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This treatment is now FDA-approved and available for Dravet syndrome under the brand name Fintepla. If your child has Dravet syndrome and still has frequent seizures despite other medicines, ask your epilepsy specialist whether fenfluramine could help. The trial showed it works well when added to current treatments.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open epilepsy trials
Capturing Autobiographical Memory Formation in Real World Spaces Using Multimodal Recordings
The goal of this observational study is to develop novel methods for integrating multimodal data streams with invasive neural recordings to study autobiographical memory (AM) formation in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) for epilepsy treatment. The main questions it aims to answer are: How does the brain encode and retrieve real-world autobiographical memories? Can multimodal data integration enhance our understanding of memory-related cognitive and neural mechanisms? Participants will: * Use a smartphone-based recording application (CAPTURE app) to collect real-world data. * Have their wearable sensor data (e.g., audio-visual, accelerometry, GPS, autonomic physiology, eye tracking) synchronized with invasive neural recordings. Researchers will analyze these multimodal data streams to develop new analytic approaches for studying memory formation in naturalistic settings, with the long-term goal of informing neuromodulation-based memory enhancement treatments for individuals with memory disorders.
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures