Outcomes After Planned Discontinuation of AntiSeizure Medication

NCT07750496 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: HUM002834555K23AG081463-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Number of patients recruited per year

  The researchers will observe the number of patients who consented divided by the number of patients who were eligible

  Recruitment Period (approximately 2 years)

• Number of planned study visits attended per patient within 1 year of follow-up for each patient

  1 year

• Number of patients who adhere to the assigned treatment protocol within 1 year for each patient

  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

  1 year

• Qualitative feedback per exit interview at 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.

  1 year

Secondary Outcomes (13)

• Quality of Life in Epilepsy-31 scale (QOLIE)

  3 months and 1 year

• Beck Depression Inventory-II (BDI-II)

  3 months and 1 year

• Generalized Anxiety Disorder-7 (GAD-7)

  3 months and 1 year

• Patient Global Impression-Change scale (PGI-C)

  3 months and 1 year

• Verbal memory immediate recall

  3 months and 1 year

Study Arms (1)

Discontinue antiseizure medications

EXPERIMENTAL

Drug: Discontinue antiseizure medications

Interventions

Discontinue antiseizure medications DRUG

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.

Discontinue antiseizure medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Terman, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Terman, MD, MS

CONTACT

734-936-9020; sterman@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Neurology

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: completion of each project, i.e., upon acceptance of each analysis for publication. Individual patient data will be stored and archived for the life of the project on UM-approved research-secured password-protected HIPAA-compliant computing environments designed for this purpose.
• Access Criteria: Following reasonable requests to the study team researchers will need to sign a data use agreement with UM.

Locations

US (1)