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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Has taken huperzine A within the past year
✕. 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.

Effects of SPN-817 on safety and tolerability

Timeframe: 72 weeks

NCT IDNCT05518578

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Supernus Clinical Trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Has taken huperzine A within the past year
✕. 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.