Outcomes After Planned Discontinuation of AntiSeizure Medication
Recruiting · NCT07750496 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States