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Recruiting NCT07750496

Outcomes After Planned Discontinuation of AntiSeizure Medication

Phase IV Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discontinue antiseizure medications.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study Testing Outcomes After Planned Discontinuation of AntiSeizure Medication

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Quality of Life in Epilepsy-31 scale (QOLIE) [Time frame: 3 months and 1 year]
  • Beck Depression Inventory-II (BDI-II) [Time frame: 3 months and 1 year]
  • Generalized Anxiety Disorder-7 (GAD-7) [Time frame: 3 months and 1 year]
  • Patient Global Impression-Change scale (PGI-C) [Time frame: 3 months and 1 year]
  • Verbal memory immediate recall [Time frame: 3 months and 1 year]
  • Verbal memory delayed recall [Time frame: 3 months and 1 year]
  • Visual memory immediate recall [Time frame: 3 months and 1 year]
  • Visual memory delayed recall [Time frame: 3 months and 1 year]
  • Symbol digit coding [Time frame: 3 months and 1 year]
  • Shifting attention test [Time frame: 1 year]
  • Number of seizures recorded after starting the study by 1 year. [Time frame: 1 year]
  • Number of emergency room visits for seizures after starting the study by 1 year. [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07750496 · HUM00283455 · 5K23AG081463-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗