Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RNS System · 1 trial · 5 indications
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)
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.
| Arm | Type | Description |
|---|---|---|
| Condition A | ACTIVE_COMPARATOR | high-frequency short bursts (HFSB: 100 Hz, 160 µs pulse width, 200 msec burst) |
| Condition B | ACTIVE_COMPARATOR | low-frequency long bursts (LFLB: 5 Hz, 160 µs pulse width, 5 sec burst) |
| Name | Type | Description |
|---|---|---|
| RNS System | DEVICE | The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs. |
Inclusion Criteria: * Participant is 15 years of age or older for first cohort; 12 years of age or older for second cohort. Note that age requirements for eligibility differ by cohort, as follows: the age limit for Cohort 1 is 15 years of age and above and the age limit for Cohort 2 may decrease to...
The RNS System is an investigational device being studied for the treatment of epilepsy, specifically in patients with Lennox-Gastaut syndrome and intractable seizures. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
The RNS System is developed by Neuropace, Inc., a company traded on the stock exchange under the ticker symbol NPCE. The company is conducting clinical trials to evaluate the device's safety and effectiveness in treating epilepsy.
The RNS System is currently in Phase 2 clinical development. It is being evaluated in an active clinical trial for epilepsy, including Lennox-Gastaut syndrome, and has not yet received regulatory approval.
The RNS System is being studied in the RNS System LGS Feasibility Study, identified as NCT05339126. This Phase 2 trial is active but not recruiting, with an enrollment of 24 participants in the United States.
Yes, the RNS System is being evaluated in a randomized, double-blind, active-controlled clinical trial. This study design is used to compare the device against an active control in patients with epilepsy, including those with Lennox-Gastaut syndrome.