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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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DBS for Epilepsy New Enrollment PAS


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General
Study Status Progress Adequate
Application Number P960009 S219/ PAS001
Date Current Protocol Accepted 10/28/2020
Study Name DBS for Epilepsy New Enrollment PAS
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 Design Description 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 Description 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 A total of 216 subjects will be enrolled in the study to ensure that at least 140 subjects will be implanted with the DBS device and at least 112 subjects will have data through 3 years of follow-up, including diary data between Months 30-36.
Data Collection 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%.

Primary Safety:

To demonstrate that there is not a 20% worsening in total seizure frequency overtime in subjects treated with the DBS system beginning at DBS + CMM Months 6-12 and extending through DBS + CMM Year 3.

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
Interim or Final Data Summary
Actual Number of Patients Enrolled 3
Actual Number of Sites Enrolled Plan to include 20 in the US and Europe


DBS for Epilepsy New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/26/2018 10/22/2018 On Time
one year report 04/27/2019 04/11/2019 On Time
18 month report 10/26/2019 10/25/2019 On Time
30 month report 10/26/2020 10/21/2020 On Time
three year report 04/26/2021   Overdue
four year report 04/26/2022    
five year report 04/26/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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