NCT07750496 · University of Michigan
Outcomes After Planned Discontinuation of AntiSeizure Medication
(STOP-ASM)
What this study is about
The main purpose of this study is to understand the effects of continuing versus discontinuing antiseizure medications after a period of seizure-freedom. Physician guidelines endorse that after a period of seizure-freedom, the risk of another seizure may be low enough to allow patients to consider coming off antiseizure medication to see if they still need it.
View original scientific description
The main purpose of this study is to understand the effects of continuing versus discontinuing antiseizure medications after a period of seizure-freedom. Physician guidelines endorse that after a period of seizure-freedom, the risk of another seizure may be low enough to allow patients to consider coming off antiseizure medication to see if they still need it. However, evidence is limited regarding how much continuing antiseizure medication still reduces seizures versus increases side effects after a patient has been treated for a while. This study will determine whether discontinuing antiseizure medications benefits patients.
Interventions
DRUG
Discontinue antiseizure medications
Discontinue 1 antiseizure medication. Patients will discontinue 1 of their current antiseizure medications, reducing by 25% every approximately 2 weeks in the discontinuation group or with an individualized taper plan agreed. Participants will attend approximately 5 study visits: once at the beginning, and then four quarterly visits. Each visit may last approximately 1-2 hours. These visits would be conducted by Zoom, unless participants want to conduct visits in-person or need to conduct over the phone.
Primary outcome measures
Number of patients recruited per year
Time frame: Recruitment Period (approximately 2 years)
The researchers will observe the number of patients who consented divided by the number of patients who were eligible
Number of planned study visits attended per patient within 1 year of follow-up for each patient
Time frame: 1 year
Number of patients who adhere to the assigned treatment protocol within 1 year for each patient
Time frame: 1 year
the number of patients who tapered off their antiseizure medication (ASM) within 2 months of consent or started tapering off their ASM but had a seizure before being able to fully taper off
Qualitative feedback per exit interview at 1 year
Time frame: 1 year
This will entail a 30-minute qualitative discussion with the patient and caregivers if applicable to receive any feedback about study procedures. The study will ask patients and caregivers what went well, what could be improved, what participants thought of recruitment and retention and data collection procedures, and the intervention. Responses will be purely qualitative via a discussion with the patient and summarized.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosis of epilepsy
- At least 2 years since participants most recent seizure
- At most 35% calculated 1-year post-discontinuation seizure risk, based upon the existing multivariable calculator if they are on only 1 ASM, otherwise no such restriction if they are more than 1 ASM
- Willingness to adhere to the study intervention
- Taking at least 1 antiseizure medication prior to enrollment
Exclusion criteria
- Current pregnancy or planned pregnancy during the study period
- History of epilepsy surgery
- Large space-occupying radiographic lesion such as a large cortical tumor, large artery stroke, or encephalomalacia from traumatic brain injury.
- Subject has any other clinically significant conditions or circumstances that in the judgment of the investigator or treating clinician should preclude study participation. Please note: The researchers will ask participants not to drive for 2 months after ASM discontinuation if on monotherapy, and exercise caution while driving if stopping one antiseizure medication but remaining on others
Where
- Ann Arbor, Michigan
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations