NCT06346262Active, not recruitingPhase 4
Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 22 Mar 2024
- Start date
- 5 Mar 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Diseases
- Epilepsy
- NCT number
- NCT06346262
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 31
- From 5 Mar 2024 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals prescribed opioid medications
Other illness
- Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam
- Individuals with a diagnosis of dementia
Other
- Individuals with acute narrow angle glaucoma
- Individuals with known dependence on benzodiazepines or current benzodiazepine abuse.
- Actively suicidal/homicidal
- Individuals who are unable to provide written informed consent to participate in study and who do not have a legally authorized representative or individuals who are unable to participate in study procedures.
- Pregnant women
Who the study is looking for
- Phase 1 Patient with epilepsy inclusion criteria:
- Have epilepsy
- Have experience with RM
- Be 18 years or older
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation
- Phase 1 Caregiver inclusion criteria
- Provide care support to an individual with epilepsy
- Be 18 years or older
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation
- Phase 1 Provider inclusion criteria
- Provide care for individuals with epilepsy - this may include (not limited to) physician, nurse practitioner, physician assistant, nurse, social worker, psychologist
- Be 18 years or older
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation
- Have epilepsy
- Have experience with RM
- Be 18 years or older
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation
- Have received a previous diagnosis of epilepsy
- Be adults ≥ age 18,
- While on a regimen of anti-epileptic medication, still be experiencing bouts of seizures (e.g. frequent break through or acute repetitive seizures) distinct from their usual seizure pattern , and, in the opinion of the study epilepsy clinician, may need benzodiazepine intervention for seizure control
- Have experienced at least 3 seizures but not more than 100 seizures in the previous 6 months. If there have only been 3 seizures in the last 6 months, two of the seizures should be within approximately 24 hours of each other (not more than 48 hours apart)
- Be able to speak and understand English
- Be able to provide written, informed consent to study participation
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.