Recruiting
Phase 2

SPN-817

Sponsor:

Supernus Pharmaceuticals, Inc.

Code:

NCT07141329

Conditions

Focal Onset Seizures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SPN-817

Study Details

Brief summary:

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

Conditions

Focal Onset Seizures

Study ID

NCT07141329

Start date

Jul 30, 2025

Status verified date

Oct, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Completed antecedent SPN-817 double-blind study
2. 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:

1. Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures
2. 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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SPN-817

SPN-817, bid

Interventions

SPN-817

SPN-817 starting at 0.25 mg bid up to 4.00 mg bid

Primary outcome measure

  • Incidence of treatment-emergent adverse events [ Time Frame: Week 1-Week 52 ]

Central Contacts and Locations

Central contacts

Supernus Clinical Trials

240-403-5838clinicaltrials@supernus.com

Navid Saeidi, MS

240-403-5328nsaeidi@supernus.com

Locations

Medsol Clinical Research Center

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

Maria Vasconcelos, RN

941-623-9744mvasconcelos@medsolcrc.com

More Information

Sponsor

Supernus Pharmaceuticals, Inc.

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Keywords

  • focal seizures
  • focal epilepsy
  • open-label extension
  • anti-seizure medication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Supernus Pharmaceuticals, Inc. on 2025-10-10.