Outcomes After Planned Discontinuation of AntiSeizure Medication

Официальное название

Study Testing Outcomes After Planned Discontinuation of AntiSeizure Medication

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Number of patients recruited per year [Срок оценки: Recruitment Period (approximately 2 years)]
• Number of planned study visits attended per patient within 1 year of follow-up for each patient [Срок оценки: 1 year]
• Number of patients who adhere to the assigned treatment protocol within 1 year for each patient [Срок оценки: 1 year]
• Qualitative feedback per exit interview at 1 year [Срок оценки: 1 year]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT07750496 · HUM00283455 · 5K23AG081463-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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