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New program helps epilepsy patients better manage rescue meds

NCT ID NCT06346262

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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