NCT06346262

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
BEHAVIORAL	SMART RM	The SMART-RM will consist of 8 group-format, 45-60 minute sessions (up to 11 participants per group), which will be collaboratively delivered by a Nurse Educator (NE) and a Peer Educator (PE).
DRUG	Valtoco Nasal Product	Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

Timeline

• Start date: 2024-03-05
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-04-04
• Last updated: 2026-03-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study