|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P960009 S219/ PAS001 |
| Date Original Protocol Accepted |
10/12/2018
|
| Date Current Protocol Accepted |
08/03/2022
|
| Study Name |
DBS for Epilepsy New Enrollment PAS
|
| Device Name |
MEDTRONIC DBS THERAPY FOR EPILEPSY
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study “Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)” will be an interventional,
global, prospective, multicenter, open-label, new enrollment, single arm, two-phases (CMM and CMM+DBS) study design to evaluate the
long-term safety and effectiveness of Medtronic DBS Therapy for epilepsy on seizure reduction in subjects newly implanted with the DBS
device (Activa™ PC Neurostimulation System or PerceptTM PC Neurostimulation System) + current medical management (CMM)
following an initial period of 3 months of CMM only. Subjects will then be clinically eligible for the DBS device + CMM. Those meeting
implant criteria will undergo DBS implant +CMM.
The CMM phase is the 3-month period prior to the CMM Month 3 Visit. The CMM phase is expected to start at the time of enrollment (CMM
Month 0 Visit) for most subjects but may start prior to enrollment for subjects with a pre-existing diary. Pre-existing diary data must be
documented in the medical record, must be robust in that the data allows the subject to meet the eligibility criteria, and be collected only after study
consent is obtained. In the case of pre-existing diary, CMM Month 0 and CMM Month 3 visits may be conducted on the same date.
The DBS + CMM phase starts with the Implant Visit and includes the Stimulation Activation Visit followed by 3-month Visit intervals until the
DBS + CMM Month 12 Visit. After completing the DBS + CMM Month 12 Visit, visit follow-up becomes annual until three years of follow-up are
complete. The subject will discontinue from the study following the completion of the DBS + CMM phase at 36 months.
|
| Study Population |
The intended study population is subjects 18 years and older diagnosed with epilepsy characterized by focal-onset seizures that are refractory to at least 3 AEDs.
|
| Sample Size |
to power this objective, approximately 140 enrollments (based on 35% pre-implant attrition) and no more than 90 implanted subjects (based on a maximum of 20% post-implant attrition or missing diary data) may be necessary to obtain approximately 72 subjects with follow-up data at 3 years.
|
| Key Study Endpoints |
Safety Endpoints
Primary Effectiveness:
To demonstrate that the total seizure frequency during CMM is reduced by 40% after 3 years of DBS + CMM.
This will be demonstrated though a percentage reduction in seizures which is statistically non-inferior to 40% from pre- implant to 3 years post-implant in patients treated with the DBS system, utilizing a margin of 10%.
Secondary:
Secondary Effectiveness Objectives:
1. To demonstrate that the total seizure frequency assessed during the CMM phase is reduced after 12 months of DBS + CMM
2. To demonstrate that the disabling seizure frequency assessed during the CMM phase is reduced after 12 months of DBS + CMM
3. To demonstrate that the frequency of seizures originating in the temporal lobe assessed during the CMM phase is reduced after 12 months of DBS + CMM
Secondary Safety Objective:
4. To characterize the Sudden Unexpected Death in Epilepsy (SUDEP) rate
|
| Follow-up Visits and Length of Follow-up |
3 years
|
