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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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This is a Phase 2b, multicenter, open-label extension, one-year, safety, tolerability, and efficacy study in adults who previously completed an applicable double-blind SPN-817 clinical study. This study will include a double-blind Dose Titration/Bridging Period of 8-10 weeks in which SPN-817 will be titrated to the participant's maximum tolerated dose based on response. Following the Dose Titration/Bridging Period, participants will enter an Open Label Extension (OLE) Period of 42-44 weeks. When participants finish the OLE Period, they will initiate a Tapering Period (up to 4 weeks) followed by an End-of-Tapering Period video contact (VC) after the last dose of study drug. The duration of study treatment before starting the 4-week Tapering Period will be one year (52 weeks).

Conditions

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Focal Onset Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPN-817

SPN-817, bid

Group Type EXPERIMENTAL

SPN-817

Intervention Type DRUG

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

Interventions

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SPN-817

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No