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RecruitingPhase 2

SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures

Supernus Pharmaceuticals, Inc. · NCT07141329

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
100
US sites recruiting
1
Study start
July 30, 2025
Record last updated
October 10, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: SPN-817

Conditions: Focal Onset Seizures

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Recruiting US locations

  • Medsol Clinical Research Center

    Port Charlotte, FL 33952

    Site contact: Maria Vasconcelos, RN · 941-623-9744 · mvasconcelos@medsolcrc.com

Study contacts (from the official record)

  • Supernus Clinical Trials · 240-403-5838 · clinicaltrials@supernus.com
  • Navid Saeidi, MS · 240-403-5328 · nsaeidi@supernus.com
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SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures (NCT07141329) | Bored Studies