New program helps epilepsy patients better manage rescue meds
NCT ID NCT06346262
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study aims to help people with epilepsy who have repeated seizures learn how to use rescue medication more effectively. In the first phase, patients, caregivers, and doctors will help design an educational program. In the second phase, about 35 adults will try the program for 6 months to see if it reduces seizures and improves quality of life.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
31 people
The number who actually took part.
- Started
-
Mar 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Inclusion criteria for PEs: * 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 Inclusion criteria for participants who will receive SMART-RM: * 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 Exclusion Criteria: Exclusion criteria for participants who will receive SMART-RM: * Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam * Individuals prescribed opioid medications * Individuals with acute narrow angle glaucoma * Individuals with known dependence on benzodiazepines or current benzodiazepine abuse. * Actively suicidal/homicidal * Individuals with a diagnosis of dementia * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Epilepsy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital
New York, New York, 10029, United States
-
University Hospitals Medical Center
Cleveland, Ohio, 44106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can lavender and lullabies help kids with epilepsy sleep better?
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Can a Comfort-Focused education program improve life with epilepsy?
- Can video games rewire young brains after injury?
- High-Fat Diet's effect on epilepsy: scientists track brain signals
- Epilepsy drug candidate put to the test in healthy volunteers