EpilepsyPhase 4STOP-ASMNCT07750496
Outcomes After Planned Discontinuation of AntiSeizure Medication
A Phase 4 study testing Discontinue antiseizure medications in people with Epilepsy, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Discontinue antiseizure medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Samuel Terman, MD, MS, 734-936-9020, sterman@umich.edu
Samuel Terman, MD, MS
About this study
Official title: Study Testing Outcomes After Planned Discontinuation of AntiSeizure Medication
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.
- Conditions
- Epilepsy
- Being tested
- Discontinue antiseizure medications
- Keywords
- Seizure, Antiseizure medications, Seizure Free, Feasibility, Acceptability, Discontinue medication
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinue antiseizure medicationsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Discontinue antiseizure medications | Experimental | Not described Receives: Drug: Discontinue antiseizure medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Recruitment Period (approximately 2 years)
Number of planned study visits attended per patient within 1 year of follow-up for each patient
Measured: 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
Measured: 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.
Measured: 1 year
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Number of seizures recorded after starting the study by 1 year.
Measured: 1 year
Number of emergency room visits for seizures after starting the study by 1 year.
Measured: 1 year
Number of inpatient visits for seizures after starting the study by 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Samuel Terman, University of Michigan
- Investigators
- Samuel Terman, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750496
- Sponsor's protocol ID
- HUM00283455
- Other IDs
- 5K23AG081463-02
- Acronym
- STOP-ASM
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Testing Outcomes After Planned Discontinuation of AntiSeizure Medication
- ClinicalTrials.gov ID
- NCT07750496
- Acronym / sponsor ID
- STOP-ASM / HUM00283455
- Conditions
- Epilepsy
- Keywords
- Seizure, Antiseizure medications, Seizure Free, Feasibility, Acceptability, Discontinue medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discontinue antiseizure medications | Experimental | Drug: Discontinue antiseizure medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinue antiseizure medicationsDiscontinue 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. | Drug | Discontinue antiseizure medications |
Primary outcome
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.
13 secondary outcomes
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
Number of inpatient visits for seizures after starting the study by 1 year.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Terman, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Discontinue antiseizure medications in people with Epilepsy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Terman, MD, MS (734-936-9020, sterman@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients recruited per year (time frame: Recruitment Period (approximately 2 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.