RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults with Focal Onset Seizures

Launched by SUPERNUS PHARMACEUTICALS, INC. · Jan 27, 2025

Keywords

ClinConnect Summary

The RENAISSANCE 2 trial is a research study looking at a new medication called SPN-817 for adults who have focal onset seizures, which are a type of seizure that starts in one specific area of the brain. This study is designed to find out if SPN-817 is safe and effective for people who have not had success with other epilepsy medications. To participate in this trial, individuals need to be between 18 and 65 years old, have been diagnosed with treatment-resistant focal epilepsy, and have not found relief from at least two different seizure medications. They will also need to keep track of their seizures using a diary, either on their own or with help.

Those who join the study will be randomly assigned to receive either SPN-817 or a placebo (a pill that doesn’t contain active medication) without knowing which one they have. This helps researchers compare the effects of the new drug to those of a non-active treatment. Participants will be monitored closely, and they can expect to have regular check-ins and assessments throughout the study. It’s important to know that certain health conditions, recent treatments, or specific medications may prevent someone from joining, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

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.