2026-05-28
minor
Study Identification, Study Status, Oversight, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2026-10→2027-08
Completion date2026-10→2027-08
Enrollment target258→216
Eligibility criteria+117 characters
[...] ely dosed ASM drug schedules;
Able to keep accurate Seizure electronic diaries [eDiaries] (with the aid of a caregiver as needed);
Has a body mass in [...] o the first dose of SM (during the days of baseline Seizure electronic diary [eDiary] data collection) and no more than a consecutive 21-day period that was seizurefree freeof these seizures.
To be eligible for the study, participants must comply with the eDiary on at least 9080% of the days of baseline data collection;
Exclusion Criteri [...] ide attempt;
Chronic concomitant therapy with non-ASMs that arehave potent cholinergic (central or peripheral) o [...] [...]
Secondary endpoints5 entries, revised
Incidence of treatment-emergent adverse events (AEsTEAEs)
Study description+228 characters
[...] 0 weeks).
In both treatment groups, open-label ondansetron (or another concomitant medication to assess pharmacological approaches to managing cholinergic adverse events [AEs]) will be taken (8 mg oral [PO]) will be taken prophylactically approximately 30 minutes before each study medication (SM) dose (ie, BID) during the firstTitration 5 weeks of dose titrationPeriod as an antiemetic; after the first 5 weeks, ondansetron may be taken as needed as either a preventative or therapeutic antiemetic.
After the target dose of 3.0-4.0
mg BID is reached, participants will enter the Maintenance Period [...] [...]
Study sitescontacts updated at 1 of 1 site
Study titlerevised
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults withWith Focal Onset Seizures
2025-02-03
minor
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields