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

Phase 2RecruitingNCT07141329

Supernus Pharmaceuticals, Inc.100 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Focal Onset Seizures

Interventions

SPN-817DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medsol Clinical Research Center

Port Charlotte, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events

The percent of participants who took at least one dose of SPN-817 and reported at least one adverse event during the 1-year SPN-817 Treatment Period

Time frame: Week 1-Week 52

Secondary Outcomes

Percent change (PCH) from baseline in quantifiable focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period

Percent change in 28-day frequency of quantifiable focal seizures during the 1-year Treatment Period relative to baseline

Time frame: Baseline and Treatment Period (Week 1-52)

Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline

Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 1-year Treatment Period relative to baseline.

Time frame: Baseline and Treatment Period (Week 1-52)

Proportion of participants experiencing seizure freedom

100% reduction in 28-day frequency of focal seizures during the Treatment Period relative to baseline

Time frame: Baseline and Treatment Period (Week 1-52)

Percentage of seizure-free days over the 1-year SPN-817 Treatment Period

The number of seizure-free days reported for each participant divided by the total number of days with seizure data reported, multiplied by 100.

Time frame: Week 1-Week 52

Central Contacts

Supernus Clinical Trials

CONTACT

240-403-5838 clinicaltrials@supernus.com

Navid Saeidi, MS

CONTACT

240-403-5328 nsaeidi@supernus.com

Data from ClinicalTrials.gov

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