Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy (NCT05518578) | Clinical Trial Compass
RecruitingPhase 2
Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
United States, Australia60 participantsStarted 2023-02-07
Plain-language summary
This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A diagnosis of treatment resistant epilepsy as adjudicated by the Epilepsy Study Consortium.
. Is male or female, aged 18 to ≤ 70 years at screening.
. Is able to read, understand, and sign the Informed Consent Form (ICF). If the participant is unable to sign informed consent, a Legally Authorized Representative (LAR) will complete the ICF.
. Ability to keep accurate seizure diaries (with the aid of a caregiver as needed).
. Weight within the normal or overweight ranges according to accepted values of the Body Mass Index Chart (18.0 to 40 kg/m2).
. Is able to swallow capsules whole without crushing, chewing, or cutting.
. Is willing to adhere to all study procedures and able to attend study visits within the specified time windows.
. Failure of at least 2 tolerated, appropriately chosen and adequately dosed ASM drug schedules to achieve sustained seizure freedom.
Exclusion criteria
. Has taken huperzine A within the past year
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Is planning to become pregnant or impregnate spouse, not using an acceptable method of birth control (defined as use of double-barrier birth control methods, use of oral contraceptives, or surgical sterilization), pregnant, or nursing.
. Participants with Lennox-Gastaut syndrome. Participants should also be excluded in case of nondiagnostic information.
. Has non-epileptic events that could be confused by the patient and/or study staff as epileptic seizures.
. Has only seizures that are difficult to count; for example, has seizures that are not clinically observable.
. Has a history of only seizure clusters, for example, seizure clusters defined as multiple seizures with at least one seizure within 30 minutes of the previous seizure.
. Has a history of status epilepticus in the 6 months prior to Screening.
. Change in ASM regimen in the last 28 days prior to screening. No changes in ASMs are allowed during the Screening, Titration/Optimization, or Maintenance Period. Changes in ASM regimen (including any diet plan used as an ASM) are allowed during the OLE Period only.