NCT06798896 RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
| NCT ID | NCT06798896 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Supernus Pharmaceuticals, Inc. |
| Condition | Focal Onset Seizures |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 216 participants in total. It began in 2024-12-30 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 2 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.
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 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.
Contact & Investigator
Maciej Gasior, MD, PhD
STUDY DIRECTOR
Supernus Pharmaceuticals, Inc.
Frequently Asked Questions
Who can join the NCT06798896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Focal Onset Seizures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06798896 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06798896 currently recruiting?
Yes, NCT06798896 is actively recruiting participants. Contact the research team at clinicaltrials@supernus.com for enrollment information.
Where is the NCT06798896 trial being conducted?
This trial is being conducted at Port Charlotte, United States.
Who is sponsoring the NCT06798896 clinical trial?
NCT06798896 is sponsored by Supernus Pharmaceuticals, Inc.. The principal investigator is Maciej Gasior, MD, PhD at Supernus Pharmaceuticals, Inc.. The trial plans to enroll 216 participants.