Phase 4
N=230
RNS® System LTT Study
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00572195 ↗Enrolled (actual)
230
Serious AEs
77.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Serious Adverse Events (SAE) — 177 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- RNS® System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NeuroPace
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAE) |
177 | — |
| PRIMARY Percentage Change From Baseline in Seizure Frequency |
-31.5; -46.2; -46.7; -50.3; -58.3; -61.1 | <0.05 sig |
| SECONDARY Responder Rate |
33.2; 46.7; 47.6; 50.2; 56.4; 57.8 | — |
| SECONDARY QOLIE (Quality of Life in Epilepsy) |
46.1; 49.2; 49.3; 48.8; 48.1; 48.4 | <0.0001 sig |
| SECONDARY Adverse Event Rate |
228 | — |
Summary
The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.
Eligibility Criteria
Inclusion Criteria
- Subject has completed either the RNS® System Pivotal or Feasibility study
- Subject has an implanted RNS® System
- Subject has elected to continue to receive responsive neurostimulation therapy after completion of the RNS® System Pivotal or Feasibility study
- Subject is able to attend scheduled appointments for the RNS® System LTT study
Exclusion Criteria
- Subject has active psychiatric or medical illness that makes it inadvisable for the subject to continue to receive responsive neurostimulation therapy with the RNS® System
- Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily generalized seizures during the RNS® System Pivotal or Feasibility study
- Subject has been noncompliant with scheduled appointments during the RNS® System Pivotal or Feasibility study
- Subject has been noncompliant with maintaining seizure diaries during the RNS® System Pivotal or Feasibility study
- Informed consent cannot be obtained from subject or caregiver
Data sourced from ClinicalTrials.gov (NCT00572195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.