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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P960009 S219/ PAS002 |
| Date Original Protocol Accepted |
12/17/2025
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| Date Current Protocol Accepted |
12/17/2025
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| Study Name |
EPAS using RWD from the MORE Registry
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| Device Name |
MEDTRONIC DBS THERAPY FOR EPILEPSY
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| Clinical Trial Number(s) |
NCT00101933
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| General Study Protocol Parameters |
| Study Design |
Other Study Design
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| Data Source |
Other Data Source
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Subjects will be selected from the MORE registry using the previously approved Epilepsy Post-Approval Study (EPAS) study inclusion and exclusion criteria, creating an ‘EPAS-like’ subgroup (EPAS-Like Cohort Criteria).
Primary Effectiveness Objective
- To evaluate the changes in total seizure frequency at 3 years
Secondary Effectiveness Objectives
- To evaluate the reduction in total seizure frequency assessed during the baseline phase to 12 months of DBS
- To evaluate the reduction in disabling seizure frequency assessed during the baseline phase to 12 months of DBS
- To evaluate the reduction in frequency of seizures originating in the temporal lobe assessed during the baseline phase to 12 months of DBS
Secondary Safety Objective
- To characterize the SUDEP rate
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| 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
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| Sample Size |
There are 90 subjects that met the criteria.
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| Key Study Endpoints |
Safety Endpoints
Primary Effectiveness:
To demonstrate that the total seizure frequency during is reduced by 40% after 3 years.
Secondary:
Secondary Effectiveness Objectives:
1. To demonstrate that the total seizure frequency assessed during the phase is reduced after 12 months
2. To demonstrate that the disabling seizure frequency assessed during the is reduced after 12 months
3. To demonstrate that the frequency of seizures originating in the temporal lobe assessed during the phase is reduced after 12 months
Secondary Safety Objective:
4. To characterize the Sudden Unexpected Death in Epilepsy (SUDEP) rate
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| Follow-up Visits and Length of Follow-up |
3 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
From the MORE registry Full Analysis Set of 170 subjects across 24 sites, a subset of 90 subjects from 20 sites were evaluated based on EPAS study-like
eligibility criteria.
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| Actual Number of Sites Enrolled |
20
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| Patient Follow-up Rate |
54 (60%) of the subset of 90 subjects completed 3-years follow-up
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| Final Safety Findings |
The safety of Medtronic DBS Therapy for Epilepsy was studied in 90 EPAS-like implanted subjects who accumulated 320 years of device experience. In total, 251 AEs in 74 subjects (82.2%) and 88 SAEs in 41 subjects (45.6%) were reported over 3 years of FU. The most frequently reported event (>5% of EPASlike subjects) was seizure (AE: n=19, 21.1%; SAE: n=12, 13.3%). There were 8 AEs of depression (n=6), 1 AE suicidality (n=1), and 10 AEs of memory impairment (n=9) and all were assessed by the site as being related to the therapy. For seizure AEs, 52 were attributed to epilepsy (n=33), 17 AEs were related to therapy (n=13), 1 AE was related to procedure (n=1), and 0 seizure AEs were related to the device. There were no USADEs reported in the EPAS-like cohort.
Two deaths occurred within the EPAS-like cohort. One of the deaths was assessed by the investigators as Possible SUDEP and the other death was due to endocarditis (Not SUDEP). Both deaths occurred more than 2 years after device implant and neither were related to the device or the therapy.
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| Final Effect Findings |
There was a median 51.3% [95% CI: 35.8% - 65.0%] reduction in total seizures from Baseline at Year 3. Similarly, the responder rate was 53.7% at the Year 3 follow-up.
The impact of missing data and dropouts were evaluated with sensitivity analyses, including Completer 2 Months (-50.8%), 70 Day Diary Completers (-51.1%) and repeated MI analyses (range: -48.3% to -55.1%).
These analyses showed similar rates of seizure reduction, suggesting the missing data had minimal
impact on improvement in outcomes.
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| Study Strengths & Weaknesses |
Strengths: All patients had many years of drug-resistant partial onset seizures and were implanted with the Medtronic DBS system and Patients were followed for a minimum of 2 years, with many reaching 3 years of follow-up.
Weakness: incomplete follow-up data, single arm study (no comparison), low number of subjects, greater variation in patient baseline characteristics, including differences in medical history, concomitant implants/devices, and other factors; greater variation in DBS targeting permitted in MORE due to real-world use settings; and analyses derived from registry data are frequently post-hoc, and therefore Type I error rates may be inflate
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| Recommendations for Labeling Changes |
Yes
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