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NCT05339126 · ClinicalTrials.gov registry record · Phase 2
RNS System LGS Feasibility Study
A Phase 2 study of Epilepsy and Seizures, sponsored by NeuroPace.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 6
- Study locations
NCT05339126 is a Phase 2 study of Epilepsy and Seizures that is active but no longer recruiting, run by NeuroPace. The registered enrollment target is 24 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT05339126, a Phase 2 study of Epilepsy and Seizures, is active but no longer recruiting, sponsored by NeuroPace.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 6
- Study locations
Study Summary
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS.
Conditions Studied
Interventions
- DEVICE RNS System
Study Locations (6)
New York
- NYU Langone Medical Center - New York
- Mount Sinai Hospital - New York
Alabama
- University of Alabama at Birmingham - Birmingham
California
- University of California, San Francisco - San Francisco
Georgia
- Emory University - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-10-04 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05339126
The ClinicalTrials.gov registry entry for NCT05339126 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 24 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 (97% lower). The listed sponsor is NeuroPace, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which RNS System is the first listed.
NCT05339126 reports 6 study locations spanning 5 distinct geographic areas - top geographies include New York, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT05339126 about?
NCT05339126 is a clinical study titled "RNS System LGS Feasibility Study". To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseiz...
What is the current status of trial NCT05339126?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2022-10-04. Estimated completion is 2026-12-31.
What conditions does trial NCT05339126 study?
This clinical trial studies the following conditions: Epilepsy, Seizures, Lennox Gastaut Syndrome, Lennox-Gastaut Syndrome, Intractable, Seizures, Generalized.
What interventions are being tested in trial NCT05339126?
The interventions under investigation include: RNS System (DEVICE).
Who is sponsoring clinical trial NCT05339126?
This trial is sponsored by NeuroPace, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05339126 being conducted?
This trial has 6 study locations across Alabama, California, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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