Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05339126 | RNS System LGS Feasibility Study | PHASE2 | ACTIVE NOT_RECRUITING | 24 | — | — | Oct 4, 2022 | Dec 31, 2026 | Jan 12, 2026 | 6 | United States |
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...