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NCT06346262 · ClinicalTrials.gov registry record · Phase 4
Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
A Phase 4 study of Epilepsy, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06346262: Recruiting Phase 4 study of Epilepsy, sponsored by University Hospitals Cleveland Medical Center.
NCT06346262 is a Phase 4 study of Epilepsy that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 30 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06346262, a Phase 4 study of Epilepsy, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- BEHAVIORAL SMART RM
- DRUG Valtoco Nasal Product
Study Locations (2)
New York
- Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital - New York
Ohio
- University Hospitals Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 4 |
What NCT06346262 shows while recruiting
NCT06346262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which SMART RM is the first listed.
NCT06346262 reports a single indexed study location in New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT06346262 about?
NCT06346262 is a clinical study titled "Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care". 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 ...
What is the current status of trial NCT06346262?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2024-03-05. Estimated completion is 2026-09-01.
What conditions does trial NCT06346262 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT06346262?
The interventions under investigation include: SMART RM (BEHAVIORAL), Valtoco Nasal Product (DRUG).
Who is sponsoring clinical trial NCT06346262?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06346262 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06346262's enrollment target sits among peer trials
30 109th of 160 higher than 41 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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