Recruiting

Antiseizure Medication

Sponsor:

University of Michigan

Code:

NCT07750496

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Discontinue antiseizure medications

Study Details

Brief summary:

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.

Conditions

Epilepsy

Study ID

NCT07750496

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Discontinue antiseizure medications

Interventions

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 measure

  • Number of patients recruited per year [ Time Frame: Recruitment Period (approximately 2 years) ]
  • 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 ]
  • Qualitative feedback per exit interview at 1 year [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Samuel Terman, MD, MS

734-936-9020sterman@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Samuel Terman, MD, MS

734-936-9020sterman@umich.edu

Principal Investigator:

Samuel Terman, MD, MS

More Information

Sponsor

University of Michigan

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Seizure
  • Antiseizure medications
  • Seizure Free
  • Feasibility
  • Acceptability
  • Discontinue medication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-08-06.