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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 is a Phase 3 study that has completed, run by NeuroPace. The registered enrollment target is 240 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00264810
The ClinicalTrials.gov registry entry for NCT00264810 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NeuroPace, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RNS® System implantation is the first listed.
NCT00264810 reports 0 study locations.
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.
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