Evaluating SPN-817 for adults with focal onset seizures

RENAISSANCE 2: a Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults with Focal Onset Seizures

This study is testing a new medication called SPN-817 to see if it can help adults with focal onset seizures who haven't found relief from other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Supernus Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 1 site (Port Charlotte, Florida)
• Trial ID: NCT06798896 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with treatment-resistant focal epilepsy who have failed multiple anti-seizure medications.

Not a fit: Patients who have not been diagnosed with focal onset seizures or those who have not previously failed multiple anti-seizure medication regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with treatment-resistant focal onset seizures.

How similar studies have performed: Other studies have shown promise in using adjunctive treatments for focal seizures, but the specific approach with SPN-817 is novel.

Eligibility criteria

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 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 eDiary data collection) and no more than a consecutive 21-day period that was seizure free. To be eligible for the study, participants must comply with the eDiary on at least 90% 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 are cholinergic or anticholinergic.
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 this trial is running

Port Charlotte, Florida

• Medsol Clinical Research Center — Port Charlotte, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Supernus Clinical Trials

Conditions Focal Onset Seizures; focal seizures; focal epilepsy; Phase 2; anti-seizure medication