SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPN-817.
- Who it may be relevant to
- Registry conditions: Focal Onset Seizures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
Overview
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
Detailed description
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).
Interventions
- Drug SPN-817
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
Primary outcome measures
- Incidence of treatment-emergent adverse events [Time frame: Week 1-Week 52]
Secondary outcome measures (4)
- Percent change (PCH) from baseline in quantifiable focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period [Time frame: Baseline and Treatment Period (Week 1-52)]
- Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline [Time frame: Baseline and Treatment Period (Week 1-52)]
- Proportion of participants experiencing seizure freedom [Time frame: Baseline and Treatment Period (Week 1-52)]
- Percentage of seizure-free days over the 1-year SPN-817 Treatment Period [Time frame: Week 1-Week 52]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medsol Clinical Research Center — Port Charlotte
Identifiers
NCT: NCT07141329 · 817P210