Clinical Trial

Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care

Active, Not Recruiting Phase 4
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Summary
This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings. Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-07
notable Primary completion pushed: 2026-09-01 -> 2026-12-31 2026-07-07
minor Completion pushed: 2026-09-01 -> 2026-12-31 2026-07-07
Trial Details
NCT Number NCT06346262
Lead Sponsor University Hospitals Cleveland Medical Center
Conditions Epilepsy
Enrollment 31 participants
Start Date 2024-03-05
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-06