A Phase 4 interventional study of Discontinue antiseizure medications in Epilepsy, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by University of Michigan · Phase 4, Interventional, and Treatment
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
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
Time frame: 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.
Time frame: 1 year
Quality of Life in Epilepsy-31 scale (QOLIE)
This is a survey of health-related quality of life for adults aged ≥18 years diagnosed with epilepsy. The self-reported questionnaire contains 7 multi-item sub-scales that cover the following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. A total of 31 items are measured using Likert scales and scored by weighting and summing each item. The score ranges 0-100, with higher scores indicating better quality of life.
Time frame: 3 months and 1 year
Beck Depression Inventory-II (BDI-II)
This is a 21-item multiple-choice self-report inventory used to measure the severity of depression symptoms according to criteria listed in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Items include statements relating to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss in interest in sex. Participants will respond to each item based on a 2-week time period, using a 4-point scale from 0 to 3. A score of 0 to 13 indicates minimal depression, 14 to 19 indicates mild depression, 20 to 28 moderate depression, and 29 to 63 indicates severe depression.
Time frame: 3 months and 1 year
Generalized Anxiety Disorder-7 (GAD-7)
The GAD is a 7-item self-reported screening tool that measures the severity of generalized anxiety disorder symptoms. The 7 items assess feeling nervous/anxious, being able to stop worrying, worrying too much, trouble relaxing, being restless, becoming easily annoyed/irritable, and feeling afraid something awful might happen. Participants will respond to each item based on a 2-week time period, using a 4-point scale from 0 to 3. A score of 0 to 4 indicates minimal anxiety, 5 to 9 indicates mild anxiety, 10 to 14 indicates moderate anxiety, and 15 to 21 indicates severe anxiety.
Time frame: 3 months and 1 year
Patient Global Impression-Change scale (PGI-C)
The Patient Global Impression-Change scale is a self-reported scale that will be used to assess perception of change in participants overall status since baseline using a 7-point Likert scale, anchored at 1= "very much improved" and 7= "very much worse".
Time frame: 3 months and 1 year
Verbal memory immediate recall
This measures recognition memory for words. Fifteen words are presented, one by one, on the screen every 2 seconds. For immediate recognition, the participant has to identify those words nested among fifteen new words. The test is scored by the number of correct hits out of 15.
Time frame: 3 months and 1 year
Verbal memory delayed recall
Verbal memory delayed recall: After 6 more tests, there is a delayed recognition trial of the original words from the immediate recall test. The test is scored by the number of correct hits out of 15.
Time frame: 3 months and 1 year
Visual memory immediate recall
This measures recognition memory for figures or shapes. The protocol is similar to the verbal memory test. Fifteen geometric figures are presented, one by one, on the screen. For immediate recognition, the participant has to identify those figures nested among 15 new figures. The test is scored by the number of correct hits out of 15.
Time frame: 3 months and 1 year
Visual memory delayed recall
Visual memory delayed recall: The protocol is similar to the verbal memory test. After 5 more tests, there is a delayed recognition trial. The test is scored by the number of correct hits out of 15.
Time frame: 3 months and 1 year
Symbol digit coding
This test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The participant types in the number that corresponds to the symbol that is highlighted. Only the digits 2-9 are used, to avoid confusion between "1" and "I" on the keyboard. The computer program does not allow a person to use a numerical pad, preventing a distinct advantage for those who are skilled at using the numerical pad or for those that are right- versus left-handed. Tasks continue for about 4 minutes. The test is scored as the number of correct responses within the time limit, ranging from 0 to as many correct responses as they can achieve.
Time frame: 3 months and 1 year
Shifting attention test
This is a measure of ability to shift from one instruction set to another quickly and accurately. Participants are instructed to match geometric objects either by shape or by color. Three figures appear on the screen, one on top and 2 on the bottom. The top figure is either a square or a circle. The bottom figures are a square and a circle. The figures are either red or blue (mixed randomly). The participant is asked to match one of the bottom figures to the top figure. The rules change at random (i.e., match the figures by shape, for another, by color). The task continues for about 2.5 minutes. The test is scored as the number of correct responses and errors within the timeframe, ranging from 0 to as many correct responses as participants can achieve.
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
Number of inpatient visits for seizures after starting the study by 1 year.
Time frame: 1 year
Plan to share: Yes — All statistical code will be posted indefinitely to a personal GitHub account upon 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 University of Michigan (UM) -approved research-secured password-protected Health Insurance Portability and Accountability Act (HIPAA)-compliant computing environments designed for this purpose. Patient data, even if deidentified, will not be freely available due to university restrictions on open access to individual patient data. But deidentified data can be shared after completion of appropriate data use agreements upon reasonable request. All survey instruments will be deposited into a freely available GitHub account and included as supplemental files with publications. Also, all survey instruments will be deposited into a freely available GitHub account and included as supplemental files with publications.
Supporting information: Study protocol, Informed consent form, 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.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.
Of 33 non-industry phase 4 interventional studies under Epilepsy, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 36 months is above that.
Counting every sponsor, half of 43 studies reached it within 25 months; a quarter within 12 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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