Outcomes After Planned Discontinuation of AntiSeizure Medication

Purpose

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.

Condition

  • Epilepsy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Discontinue antiseizure medications
  • 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.

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Samuel Terman, MD, MS
734-936-9020
sterman@umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Samuel Terman, MD, MS
734-936-9020
sterman@umich.edu