Study Testing Outcomes After Planned Discontinuation of AntiSeizure Medication
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Michigan
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of patients recruited per year
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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
Arms & Interventions
Discontinue antiseizure medications
Intervention: Discontinue antiseizure medications (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of inpatient visits for seizures after starting the study by 1 year.(1 year)
- Number of emergency room visits for seizures after starting the study by 1 year.(1 year)
- 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)
- Verbal memory delayed recall(3 months and 1 year)
- Visual memory immediate recall(3 months and 1 year)
- Visual memory delayed recall(3 months and 1 year)
- Symbol digit coding(3 months and 1 year)
- Shifting attention test(1 year)
- Number of seizures recorded after starting the study by 1 year.(1 year)
Investigators
Samuel Terman
Assistant Professor in Neurology
University of Michigan