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NCT06798896 · ClinicalTrials.gov registry record · Phase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures
A Phase 2 study of Focal Onset Seizures, sponsored by Supernus Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
- 1
- Study location
NCT06798896: Recruiting Phase 2 study of Focal Onset Seizures, sponsored by Supernus Pharmaceuticals.
NCT06798896 is a Phase 2 study of Focal Onset Seizures that is actively recruiting participants, run by Supernus Pharmaceuticals. The registered enrollment target is 258 participants, above the 218-participant average among 4 other Focal Onset Seizures trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06798896, a Phase 2 study of Focal Onset Seizures, is actively recruiting participants, sponsored by Supernus Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SPN-817
Study Locations (1)
Florida
- Medsol Clinical Research Center - Port Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2024-12-30 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What NCT06798896 shows while recruiting
NCT06798896 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 4 other Focal Onset Seizures trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Focal Onset Seizures appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06798896 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06798896 about?
NCT06798896 is a clinical study titled "RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures". 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.
What is the current status of trial NCT06798896?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2024-12-30. Estimated completion is 2026-10.
What conditions does trial NCT06798896 study?
This clinical trial studies the following conditions: Focal Onset Seizures.
What interventions are being tested in trial NCT06798896?
The interventions under investigation include: Placebo (DRUG), SPN-817 (DRUG).
Who is sponsoring clinical trial NCT06798896?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06798896 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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