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NCT05147571 · ClinicalTrials.gov registry record · Phase 3
RNS System NAUTILUS Study
A Phase 3 study of Epilepsy and Generalized Tonic Clonic Seizure, sponsored by NeuroPace.
- Active
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05147571: Active Phase 3 study of Epilepsy and Generalized Tonic Clonic Seizure, sponsored by NeuroPace.
NCT05147571 is a Phase 3 study of Epilepsy and Generalized Tonic Clonic Seizure that is active but no longer recruiting, run by NeuroPace. The registered enrollment target is 100 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05147571, a Phase 3 study of Epilepsy and Generalized Tonic Clonic Seizure, is active but no longer recruiting, sponsored by NeuroPace.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.
Primary Outcome
The primary safety endpoint is the percent of participants with serious device-related adverse events (SADE) at 84 days (12 weeks) post-implant.
Conditions Studied
Interventions
- DEVICE Sham stimulation
- DEVICE Responsive stimulation
Study Locations (20)
Pennsylvania
- University of Pennsylvania - Philadelphia
- Thomas Jefferson University - Philadelphia
- UPMC - Pittsburgh
Florida
- Nicklaus Children's Hospital - Miami
- University of South Florida - Tampa
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic - Arizona - Phoenix
Colorado
- University of Colorado - Aurora
Indiana
- Indiana University Health - Indianapolis
Kansas
- University of Kansas Medical Center - Kansas City
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-08-09 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What the registry record for NCT05147571 still lists
NCT05147571 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Sham stimulation is the first listed.
NCT05147571 names 20 study sites across 17 states, led by Pennsylvania, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05147571 about?
NCT05147571 is a clinical study titled "RNS System NAUTILUS Study". To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant idiopathic generalized epilepsy.
What is the current status of trial NCT05147571?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2022-08-09. Estimated completion is 2026-03.
What conditions does trial NCT05147571 study?
This clinical trial studies the following conditions: Epilepsy, Generalized Tonic Clonic Seizure, Idiopathic Generalized Epilepsy.
What interventions are being tested in trial NCT05147571?
The interventions under investigation include: Sham stimulation (DEVICE), Responsive stimulation (DEVICE).
Who is sponsoring clinical trial NCT05147571?
This trial is sponsored by NeuroPace, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05147571 being conducted?
This trial has 20 study locations across Alabama, Arizona, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epilepsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05147571's enrollment target sits among peer trials
100 54th of 160 higher than 103 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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