SPN-817 for Seizures

Overseen By Supernus Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Supernus Pharmaceuticals, Inc.

Must be taking: Antiseizure medications

Disqualifiers: Nonepileptic events, Suicidal behavior, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SPN-817, a potential antiseizure medication, to assess its safety and effectiveness for people with seizures. The researchers aim to determine if the treatment remains effective over a long period. This trial includes individuals who have already participated in a previous study with SPN-817 and are taking a stable dose of one to four antiseizure medications. Participants must not have non-epileptic events mistaken for seizures or any serious suicidal thoughts or behavior. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop taking your current medications. The trial requires you to continue taking a stable dosage of at least one antiseizure medication.

Is there any evidence suggesting that SPN-817 is likely to be safe for humans?

Research shows that SPN-817, a specially formulated version of huperzine A, is being tested for seizures that don't respond to other treatments. In earlier studies, SPN-817 was used in adults with hard-to-treat epilepsy. These studies examined both the treatment's safety and patient tolerance.

One previous study found that some patients experienced a significant drop in seizures after long-term use of SPN-817, suggesting its potential effectiveness. However, the main focus remains on safety. So far, trials have shown that SPN-817 is generally well-tolerated, with no major safety issues reported.

This is a Phase 2 trial, indicating that earlier tests (Phase 1) have already assessed SPN-817's safety in humans. While Phase 2 focuses more on effectiveness, safety checks continue. This research aims to ensure SPN-817 remains safe over a longer period. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SPN-817 is unique because it targets seizures with a novel mechanism of action. Unlike standard treatments, which often focus on modulating neurotransmitters like GABA or glutamate, SPN-817 is derived from a different approach that promises to enhance seizure control with potentially fewer side effects. Researchers are excited about this treatment because it could offer a new option for patients who do not respond well to current medications.

What evidence suggests that SPN-817 might be an effective treatment for seizures?

Research has shown that SPN-817, the investigational treatment in this trial, offers promising results for reducing seizures. In one study, patients experienced an average seizure reduction of 58%. Another study demonstrated a 71% decrease in seizures after 15 months, with some participants seeing a 90% reduction after 32 months. These findings suggest that SPN-817 can significantly lower the number of seizures in people with epilepsy. ^{1 3 5 6 7}

Who Is on the Research Team?

Maciej Gasior, MD, PhD

Principal Investigator

Supernus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

This trial is for adults who have focal onset seizures and completed a prior SPN-817 study. Participants must be on a stable dose of 1 to 4 antiseizure medications. Those with non-epileptic seizure-like events or significant suicidal ideation or behavior are excluded.

Inclusion Criteria

I am on a stable dose of 1 to 4 seizure medications.

Completed antecedent SPN-817 double-blind study

Exclusion Criteria

Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures

Has any suicidal behavior or suicidal ideation related to Item 4 (active suicidal ideation with some intent to act without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments in the antecedent study and at Visit 1 or more than one lifetime suicide attempt

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Titration/Bridging

SPN-817 is titrated to the participant's maximum tolerated dose based on response

8-10 weeks

Open Label Extension

Participants continue receiving SPN-817 to evaluate long-term safety and efficacy

42-44 weeks

Tapering

Participants taper off SPN-817 over a period of up to 4 weeks

up to 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPN-817

Trial Overview The trial is testing the long-term safety and effectiveness of a medication called SPN-817 in individuals with partial seizures. It's an open-label extension, meaning everyone knows they're getting SPN-817, following up from a previous phase.

How Is the Trial Designed?

Group I: SPN-817 Experimental Treatment 1 Intervention

SPN-817, bid

Who Is Running the Clinical Trial?

Supernus Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

14,000+

Citations

1. aesnet.org aesnet.org/abstractslisting/the-renaissance-study-interim-results-of-a-phase-2-study-of-spn-817-in-adults-with-treatment-resistant-epilepsy

interim results of a phase 2 study of spn-817 in adults with ... For subjects in the maintenance period, median 28-day seizure frequency was reduced by 54.5% (n=19), with 81.3%, 62.5% and 18.8% experiencing ...

2. ir.supernus.com ir.supernus.com/news-releases/news-release-details/supernus-announces-promising-interim-data-ongoing-open-label

News Release Details Supernus Announces Promising Interim Data from Ongoing Open-Label Phase 2a Study of SPN-817 in Epilepsy · 58% median seizure reduction in the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05518578

Safety and Tolerability Study of SPN-817 in Adult Patients ... This is a multicenter, three-phase, long-term open-label study assessing the safety and tolerability of SPN-817 in adults 18-70 years of age with treatment ...

4. neurology.org neurology.org/doi/10.1212/WNL.98.18_supplement.1388

An Open-Label Pilot Trial Assessing the Safety and ... During the long-term SPN-817 maintenance period, the mean reduction in 28-day seizure rate was 71% after 15 months (N=3) and 90% after 32 months ...

5. aan.com aan.com/MSA/Public/Events/AbstractDetails/50529

Abstract Details Results During the long-term SPN-817 maintenance period, the mean reduction in 28-day seizure rate was 71% after 15 months (N=3) and 90% after 32 months (N=2).

6. ir.supernus.com ir.supernus.com/static-files/8d19152f-077b-4bde-9280-586d6f702da9

SPN-817 Phase 2a Study Graph includes only countable seizures (Types B, C, D, E, H, I, J, K, and L). Subjects must have at least 14 days with seizure diary reported ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07141329

NCT07141329 | SPN-817 Open-Label Extension Study in ... This is a Phase 2b, multicenter, open-label extension, one-year, safety, tolerability, and efficacy study in adults who previously completed an ...