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

May 28, 2026 updated by: Supernus Pharmaceuticals, Inc.

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 administered as an adjunctive treatment in adults with focal onset seizures that have previously failed at least 2 anti-seizure medication (ASM) regimens. Participants will be taking 1 to 4 ASMs, with at least 4 seizures during the 6-week Screening Period. Following the Screening Period, eligible participants will be randomized 2:1 to SPN-817 (3.0-4.0 mg BID) or placebo and begin the Titration Period (8-10 weeks). In both treatment groups, open-label ondansetron (or another concomitant medication to assess pharmacological approaches to managing cholinergic adverse events [AEs]) will be taken (8 mg oral [PO]) prophylactically approximately 30 minutes before each study medication (SM) dose (ie, BID) during the Titration Period as an antiemetic. After the target dose of 3.0-4.0 mg BID is reached, participants will enter the Maintenance Period (14 weeks). Ondansetron (or another concomitant medication to assess pharmacological approaches to managing cholinergic AEs) may be taken as needed as either a preventative or therapeutic antiemetic during the Maintenance Period. Participants who complete the Maintenance Period will have the opportunity to enroll in a separate open-label study for continued treatment with SPN-817. Participants who do not enroll in the open-label study will undergo a Tapering Period (up to 4 weeks) and a follow-up safety phone call.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Medsol Clinical Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo, bid
Drug: Placebo
Placebo, bid
Experimental: SPN-817
SPN-817, bid
Drug: SPN-817
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance Period
Time Frame: Baseline and Maintenance Period (Maintenance Week 1-14)
Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline
Baseline and Maintenance Period (Maintenance Week 1-14)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline
Time Frame: Baseline and Maintenance Period (Maintenance Week 1-14)
Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline.
Baseline and Maintenance Period (Maintenance Week 1-14)
PCH from baseline in focal onset seizure frequency per 28 days over the entire Treatment Period
Time Frame: Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
Percent change in 28-day frequency of focal seizures during the entire Treatment Period (Titration Period + Maintenance Period) relative to baseline
Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline
Time Frame: Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the Treatment Period (Titration Period + Maintenance Period) relative to baseline.
Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
Longest seizure-free interval over the entire Treatment Period
Time Frame: Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
The longest intervals in days between two seizures during the entire Treatment Period.
Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline through Titration Week 1 up to Week 10, Maintenance Weeks 1-14, and Tapering Period up to Week 4
The percent of subjects who took at least one dose of SPN-817 and reported at least one adverse event during SPN-817 treatment.
Baseline through Titration Week 1 up to Week 10, Maintenance Weeks 1-14, and Tapering Period up to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Supernus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maciej Gasior, MD, PhD, Supernus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 817P203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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