SPN-817 for Focal Seizures

Port Charlotte, FL

Phase 2

Recruiting

Research Sponsored by Supernus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI)

Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules

Must not have

Prior diagnosis of combined focal and generalized epilepsy syndrome as evidenced by severe developmental delay and multiple seizure types and confirmed by electroencephalography (EEG) (eg, Lennox-Gastaut syndrome). Participants should also be excluded in case of nondiagnostic information

Has taken huperzine A within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through titration week 1 up to week 10, maintenance weeks 1-14, and tapering period up to week 4

Summary

"This trial will test a new medication called SPN-817 in adults with focal onset seizures to see how well it works compared to a placebo. It will be conducted at multiple centers and will be double

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Who is the study for?

Adults with focal onset seizures, which are seizures that start in just one part of the brain. Participants must meet certain health standards to be included but specific inclusion and exclusion criteria details were not provided.Check my eligibility

What is being tested?

The trial is testing SPN-817 against a placebo to see if it's effective and safe for treating focal onset seizures. Patients will be randomly assigned to either the drug or placebo group without knowing which they're receiving.See study design

What are the potential side effects?

While specific side effects of SPN-817 aren't listed, common ones for seizure medications include dizziness, fatigue, coordination problems, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My epilepsy does not respond to treatment, as confirmed by the ESCI.

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I still have seizures despite trying at least 2 different seizure medications.

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I've been on 1-4 seizure medications for over 28 days and have followed a stable diet if applicable.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a complex epilepsy syndrome confirmed by EEG.

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I have taken huperzine A in the last 6 months.

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I am on long-term medication that affects my nervous system.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through titration week 1 up to week 10, maintenance weeks 1-14, and tapering period up to week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through titration week 1 up to week 10, maintenance weeks 1-14, and tapering period up to week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through titration week 1 up to week 10, maintenance weeks 1-14, and tapering period up to week 4 for reporting.