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Enrolling by invitationPhase 2

Long-term study of SPN-817 in adults with focal seizures

Tests SPN-817 for long-term safety and effects in adults with focal seizures.

Key facts

Who runs it
Supernus Pharmaceuticals, Inc.
Where
DO NOT EDIT, BulgariaSee the siteAlso in 4 other countries, 10 sites
Registry title
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Status
Enrolling by invitation
Phase
Phase 2
People taking part
100 people, planned
Started
30 Jul 2025
Expected to end
31 Dec 2027
Type of study
Interventional
Treatments tested
  • SPN-817
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with focal onset seizures who finished an earlier SPN-817 double-blind study. It follows long-term safety and effect of SPN-817 over one year.

Age
18 years or older
Sex
All sexes can join
Disease stage
Focal onset seizures
Earlier treatment
Must have finished the earlier SPN-817 double-blind study. Must take at least one and no more than 4 antiseizure medicines at a stable dose, kept the same during the earlier study.

Main reasons for not taking part

  • Current non-epileptic events that could be mistaken for epileptic seizures
  • Suicidal thoughts with some intent to act, or with a specific plan and intent (C-SSRS Item 4 or 5)
  • More than one suicide attempt in lifetime

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Completed antecedent SPN-817 double-blind study
  • Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs

Who cannot take part

  • Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures
  • Has any suicidal behavior or suicidal ideation related to Item 4 (active suicidal ideation with some intent to act without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments in the antecedent study and at Visit 1 or more than one lifetime suicide attempt

Where in Bulgaria

Also in 4 other countries, 10 sites

  • Article 11 CTR BGDO NOT EDIT, BulgariaNot yet recruiting

About the trial

What the trial wants to find out

This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.

The group in the trial

  • SPN-817Treatment being tested

    SPN-817, bid

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
Plain-language title
Long-term study of SPN-817 in adults with focal seizuresGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 October 2026