NCT05339126Phase 2Active not recruiting

RNS System LGS Feasibility Study

Study sponsor: NeuroPace

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2026-11-30Estimated

Enrollment · participants24Estimated

Source updated2026-09-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-09-15 · 1 field changed

Primary completion date changed

− Before

~~31 May 2026~~

+ After

30 Nov 2026

Check registry source

Posted 2026-01-12 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

Check registry source

Study details

Conditions studied

Epilepsy; Lennox Gastaut Syndrome; Lennox-Gastaut Syndrome, Intractable; Seizures; Seizures, Generalized

Treatments or interventions studied

Not recorded

Primary outcomes · main study measures

Read the study measures

measure: Safety: Annual device-related serious adverse event (SADE) rate; description: 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); timeFrame: 12 months post-implant; measure: Safety: Annual device-related serious adverse event (SADE) rate; description: 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); timeFrame: 24 months post-implant; measure: Effectiveness: Blinded evaluation period (BEP) responder rate; description: The responder rate during one or both of the stimulation conditions (A or B) is ≥ 30%. The responder rate is the proportion of participants that are responders. A responder in this study is defined as a participant who has a ≥ 35% reduction in the frequency of drop seizures compared to that participant's pre-implant baseline.; timeFrame: 12 months post-implant

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history