Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Epilepsy and Seizures, sponsored by NeuroPace.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The lower limit of the 95% confidence interval of the annual SADE rate at months 12 and 24 post-implant is less than 33.6% and 22.0%, respectively (twice the SADE rate of 16.8% and 11.0%, respectively, at the same time points in the RNS System pivotal study)
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 |
What the registry record for NCT05339126 still lists
NCT05339126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
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 lists 6 locations in 5 states (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.
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 NCT05339126's enrollment target sits among peer trials
24 123rd of 160 higher than 32 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
-
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
RECRUITING · Phase 2
-
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
RECRUITING · Phase 2
-
Study of an External Responsive Neurostimulator System on Epileptiform Activity
COMPLETED · Phase 2
-
Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI
COMPLETED · Phase 2
-
Hormone Replacement in Menopausal Women With Epilepsy
COMPLETED · Phase 2
-
Pediatric Epilepsy Study in Subjects 1-24 Months
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI