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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 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.

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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.

Conditions Studied

Epilepsy Generalized Tonic Clonic Seizure Idiopathic Generalized Epilepsy

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

FieldValue
Enrollment Target 100 participants
Start Date 2022-08-09
Est. Completion 2026-03
Phase Phase 3

Sponsor

NeuroPace

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05147571

The ClinicalTrials.gov registry entry for NCT05147571 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (89% lower). The listed sponsor is NeuroPace, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.