Actively Recruiting
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures
Led by Supernus Pharmaceuticals, Inc. · Updated on 2025-02-06
258
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.
CONDITIONS
Official Title
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of treatment-resistant focal epilepsy as confirmed by the Epilepsy Study Consortium
- Failure to achieve seizure freedom after at least 2 tolerated and appropriately dosed anti-seizure medication regimens
- Ability to keep accurate seizure diaries, with caregiver help if needed
- Body mass index between 18.0 and 40.0 kg/m2
- Stable treatment with 1 to 4 anti-seizure medications for at least 28 days before screening
- On a stable diet plan for at least 1 month before the first visit if diet is combined with medication
- At least 4 clinically observable focal onset seizures during baseline diary collection with no seizure-free period longer than 21 consecutive days
- Compliance with seizure diary on at least 90% of baseline days
You will not qualify if you...
- Use of huperzine A within the past 6 months
- Diagnosis of combined focal and generalized epilepsy syndrome with severe developmental delay and multiple seizure types
- History or presence of nonepileptic events that may be confused with seizures
- Only having seizures that are hard to count or not clinically observable
- History of seizure clusters that are too rapid to count individually
- Status epilepticus within 6 months before screening
- Epilepsy neurostimulation device implanted or activated within 1 year before screening, or epilepsy surgery within 1 year
- Suicidal behavior or ideation within 1 year before screening or recent suicide attempts
- Chronic use of non-anti-seizure medications that are cholinergic or anticholinergic
- History of more than 2 allergic reactions or one serious hypersensitivity to anti-seizure medications
- Any other condition that would prevent participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medsol Clinical Research Center
Port Charlotte, Florida, United States, 33952
Actively Recruiting
Research Team
S
Supernus Clinical Trials
CONTACT
N
Navid Saeidi, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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