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RECRUITING Phase 4

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

NCT06346262 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06346262

The ClinicalTrials.gov registry entry for NCT06346262 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06346262 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06346262?

The interventions under investigation include: SMART RM (BEHAVIORAL), Valtoco Nasal Product (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06346262?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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