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New treatment option for Focal Onset Seizures
Official title RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
ClinicalTrials.gov ID: NCT06798896
What this study is testing
What is SPN-817?
SPN-817 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for focal onset seizures.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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;
- Able to keep accurate Seizure electronic diaries [eDiaries] (with the aid of a caregiver as needed);
- Has a body mass index (BMI) between 18.0 and 40.0 kg/m2;
- 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...
You likely can't join if
- Has taken huperzine A within the past 6 months;
- Prior diagnosis of combined focal and generalized epilepsy syndrome as evidenced by severe developmental delay and multiple seizure types and...
- History of or current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures;
- Only has seizures that are difficult to count; for example, seizures that are not clinically observable;
- History of uncountable seizures, such as seizures that happen in a cluster that are too rapid to be counted individually;
- History of status epilepticus within 6 months prior to screening;
See the full eligibility criteria
- 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;
- Able to keep accurate Seizure electronic diaries [eDiaries] (with the aid of a caregiver as needed);
- Has a body mass index (BMI) between 18.0 and 40.0 kg/m2;
- 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...
- 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...
- Has taken huperzine A within the past 6 months;
- 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)...
- History of or current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures;
- Only has seizures that are difficult to count; for example, seizures that are not clinically observable;
- History of uncountable seizures, such as seizures that happen in a cluster that are too rapid to be counted individually;
- History of status epilepticus within 6 months prior to screening;
- 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...
- 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...
- Chronic concomitant therapy with non-ASMs that have potent cholinergic (central or peripheral) or potent central (only) anticholinergic pharmacology.
- History of \>2 allergic reactions to an ASM or 1 serious hypersensitivity reaction to an ASM;
- Any other reason which, in the opinion of the Investigator, would prevent the participant from taking part in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Port Charlotte, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Port Charlotte, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.