Evaluating SPN-817 for adults with focal onset seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 double-blind, randomized, placebo-controlled study aims to assess the efficacy, safety, and tolerability of SPN-817 as an adjunctive treatment for adults suffering from focal onset seizures who have not responded to at least two anti-seizure medication regimens. Participants will be randomized to receive either SPN-817 or a placebo while continuing their current anti-seizure medications. The study includes a titration period followed by a maintenance phase, with the option for participants to enroll in an open-label study for continued treatment after completion. The study will monitor seizure frequency and participant safety throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI);
2. Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules;
3. Able to keep accurate Seizure electronic diaries \[eDiaries\] (with the aid of a caregiver as needed);
4. Has a body mass index (BMI) between 18.0 and 40.0 kg/m2;
5. Treatment with a stable dose of 1 to 4 current ASMs for ≥28 days prior to screening. If following a diet plan along with the ASM, the participant should have been on a stable diet plan for at least 1 month prior to Visit 1. The diet plan should be maintained throughout the duration of the study;
6. At least 4 clinically observable focal onset seizures accepted by the ESCI prior to the first dose of SM (during the days of baseline Seizure electronic diary \[eDiary\] data collection) and no more than a consecutive 21-day period that was free of these seizures. To be eligible for the study, participants must comply with the eDiary on at least 80% of the days of baseline data collection;

Exclusion Criteria:

1. Has taken huperzine A within the past 6 months;
2. 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;
3. History of or current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures;
4. Only has seizures that are difficult to count; for example, seizures that are not clinically observable;
5. History of uncountable seizures, such as seizures that happen in a cluster that are too rapid to be counted individually;
6. History of status epilepticus within 6 months prior to screening;
7. Vagus nerve stimulation, deep brain stimulation, responsive neurostimulator system, or other neurostimulation for epilepsy device implanted or activated within 1 year prior to screening; or epilepsy surgery within 1 year prior to screening. Stimulation parameters for devices must have been stable for at least 3 months prior to Screening. Battery change for any epilepsy devices will be allowed; however, stimulation parameters must remain stable during the duration of the study;
8. 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 C-SSRS assessment in the 1 year before screening; a suicide attempt in the last 2 years before screening; or more than 1 lifetime suicide attempt;
9. Chronic concomitant therapy with non-ASMs that have potent cholinergic (central or peripheral) or potent central (only) anticholinergic pharmacology.
10. History of \>2 allergic reactions to an ASM or 1 serious hypersensitivity reaction to an ASM;
11. Any other reason which, in the opinion of the Investigator, would prevent the participant from taking part in the study.

Where it's running

• Xenoscience
  Phoenix, Arizona, United States Recruiting
• Banner University Medical Center-Phoenix
  Phoenix, Arizona, United States Recruiting
• Center for Neurosciences
  Tucson, Arizona, United States Recruiting
• University of Arizona College of Medicine - Tucson
  Tucson, Arizona, United States Recruiting
• Clinical Trials, Inc
  Little Rock, Arkansas, United States Recruiting
• Clinical Research Institute
  Los Angeles, California, United States Recruiting

+13 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Supernus Clinical Trials
• Email: clinicaltrials@supernus.com
• Phone: 240-403-5838

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Eslicarbazepine in adults with focal-onset seizures

  This project tests how eslicarbazepine works in adults with focal-onset seizures in routine care, including those who are new to treatment and those switching from carbamazepine or oxcarbazepine.

  Recruiting King Edward Medical University · Lahore, Punjab Province · NCT07793396

• Evaluating XEN1101 for Focal-Onset Seizures

  This study is testing if a new medication called XEN1101 can help people with focal-onset seizures when added to their current seizure treatments.

  Recruiting at 63 sites Phase 3 Xenon Pharmaceuticals Inc. · Little Rock, Arkansas and 102 other locations · NCT05716100

• Evaluating the impact of cenobamate on healthcare resource use in epilepsy patients

  This study looks at how using cenobamate affects the healthcare needs of people with uncontrolled focal-onset seizures.

  Recruiting at 6 sites Aziende Chimiche Riunite Angelini Francesco S.p.A · Freiburg im Breisgau, Germany and 9 other locations · NCT06922175

• Evaluating a new ultrasound treatment for drug-resistant epilepsy

  This study is testing a new ultrasound treatment for people with drug-resistant epilepsy to see if it can help reduce their seizures and improve their quality of life.

  Recruiting NaviFUS Corporation · Taipei · NCT06492720

• Low-intensity focused ultrasound treatment for drug-resistant epilepsy

  This study is testing if low-intensity focused ultrasound can help people with drug-resistant temporal lobe epilepsy have fewer seizures while they continue taking their regular medications.

  Recruiting at 3 sites Phase 1/2 NaviFUS Corporation · Palo Alto, California and 2 other locations · NCT06388707

• Cannabidiol oral solution for treating focal-onset seizures

  We will test whether a cannabidiol oral solution (CBD-OS) can reduce focal-onset seizures in people aged 12 to 75 who are taking 1–4 stable antiseizure medications.

  Recruiting at 21 sites Phase 1 Jazz Pharmaceuticals · Phoenix, Arizona and 23 other locations · NCT07233239

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.