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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 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.

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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

FieldValue
Enrollment Target 30 participants
Start Date 2024-03-05
Est. Completion 2026-09-01
Phase Phase 4

What the Registry Record Tells You About NCT06346262

The ClinicalTrials.gov registry entry for NCT06346262 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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