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NCT00264810 · ClinicalTrials.gov registry record · Phase 3
RNS® System Pivotal Study
A Phase 3 study, sponsored by NeuroPace.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
NCT00264810: Completed Phase 3 study, sponsored by NeuroPace.
NCT00264810 is a Phase 3 study that has completed, run by NeuroPace. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00264810, a Phase 3 study, has completed, sponsored by NeuroPace.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
Study Summary
The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS® System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci (two areas of the brain) that are refractory (drug-resistant or hard-to-treat) to two or more antiepileptic medications. Patients continue to receive their epilepsy medications while participating in the study.
Primary Outcome
RNS® System Acute SAE Rate = the percentage of implanted subject having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not. This outcome measure is met when the upper limit of one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracr
Interventions
- PROCEDURE RNS® System implantation
- DEVICE RNS® System responsive stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2005-12 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00264810 record still lists
NCT00264810 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which RNS® System implantation is the first listed.
NCT00264810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00264810 about?
NCT00264810 is a clinical study titled "RNS® System Pivotal Study". The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS® System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci (two areas of the brain)...
What is the current status of trial NCT00264810?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2005-12. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00264810?
The interventions under investigation include: RNS® System implantation (PROCEDURE), RNS® System responsive stimulation (DEVICE).
Who is sponsoring clinical trial NCT00264810?
This trial is sponsored by NeuroPace, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00264810's enrollment target sits among peer trials
240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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