SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
ConditionFocal Onset Seizures
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSupernus Pharmaceuticals, Inc.
About this trial
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
SPN-817
DrugSPN-817 starting at 0.25 mg bid up to 4.00 mg bid
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: SPN-817Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 52Secondary outcomes
1
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)2
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)3
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)4
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 52Sponsors and contacts
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Source ClinicalTrials.gov