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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07141329




Registration number
Help: Registration number
NCT07141329
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
19/08/2025
Date registered
Help: Date registered
26/08/2025
Date last updated
Help: Date last updated
27/10/2026

Titles & IDs
Public title
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Scientific title
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
Additional trial identifiers [1] 0 0
817P210
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Focal Onset Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - SPN-817

Experimental: SPN-817 - SPN-817, bid


Treatment: Drugs: SPN-817
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
Week 1-Week 52
Secondary outcome [1] 0 0
Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period
Timepoint [1] 0 0
Baseline and Treatment Period (Week 1-52)
Secondary outcome [2] 0 0
Proportion of participants experiencing =50% reduction in focal seizure frequency per 28 days from baseline
Timepoint [2] 0 0
Baseline and Treatment Period (Week 1-52)
Secondary outcome [3] 0 0
Proportion of participants experiencing seizure freedom
Timepoint [3] 0 0
Baseline and Treatment Period (Week 1-52)
Secondary outcome [4] 0 0
Percentage of seizure-free days over the 1-year SPN-817 Treatment Period
Timepoint [4] 0 0
Week 1-Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Supernus Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maciej Gasior, MD, PhD
Address 0 0
Supernus Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07141329