Focal Onset SeizuresPhase 2NCT06798896
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
A Phase 2 study testing SPN-817 in people with Focal Onset Seizures, run by Supernus Pharmaceuticals, Inc. at 63 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Focal Onset Seizures
- What is being tested?
- SPN-817
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 63 sitesin 5 countries
- Study dates
- 30 Dec 2024to Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Visit 1. The diet plan should be maintained throughout the duration of the study;
- 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;
Who cannot join
- 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). Participants should also be excluded in case of nondiagnostic information;
- 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;
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- 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;
- 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;
- 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.
Trial locations and contacts
63 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
63 sites in 5 countries
United States39 sites, 37 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
- Recruiting
Dent Neurologic Institute
Amherst, New York, 14226
- Recruiting
Asheville Neurology Specialists
Asheville, North Carolina, 28806
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
- Recruiting
Mid Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
- Recruiting
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28211
- Recruiting
Neurology Institute Epilepsy Center of Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Neurocare of Louisiana
Covington, Louisiana, 70433
- Recruiting
Wayne State University - Detroit Medical Center
Detroit, Michigan, 48201
- Recruiting
Advanced Neurology Epilepsy and Sleep Center/ANESC Research
El Paso, Texas, 79912
- Recruiting
Stryde Research
Frisco, Texas, 75034
- Recruiting
Northwest Florida Clinical Research Group, LLC
Gulf Breeze, Florida, 32561
- Recruiting
Northeast Regional Epilepsy Group - Hackensack
Hackensack, New Jersey, 07601
- Recruiting
UT Health Houston
Houston, Texas, 77030
- Recruiting
Ilumina Medical Research
Kissimmee, Florida, 34744
- Recruiting
Clinical Trials, Inc
Little Rock, Arkansas, 72205
- Recruiting
Clinical Research Institute
Los Angeles, California, 90048
- Recruiting
University of Louisville Physicians
Louisville, Kentucky, 40223
- Recruiting
Medstar Health Research Institute
McLean, Virginia, 22101
- Recruiting
Visionary Investigators Network
Miami, Florida, 33133
- Recruiting
University of Miami
Miami, Florida, 33136
- Recruiting
Access Community Clinical Trials
Mission Hills, California, 91345
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
- Recruiting
Yale University
New Haven, Connecticut, 06510
- Suspended
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
- Recruiting
Northwell Health - Lenox Hill
New York, New York, 10021
- Recruiting
University of California, Irvine
Orange, California, 92868
- Terminated
Research Institute of Orlando, LLC
Orlando, Florida, 32806
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
Xenoscience
Phoenix, Arizona, 85004
- Recruiting
Banner University Medical Center-Phoenix
Phoenix, Arizona, 85006
- Recruiting
Medsol Clinical Research Center
Port Charlotte, Florida, 33952
Maria Vasconcelos, RN, 941-623-9744, mvasconcelos@medsolcrc.com
- Recruiting
Cleveland Clinic Florida Martin Health
Port Saint Lucie, Florida, 34990
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14618
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
- Recruiting
Center for Neurosciences
Tucson, Arizona, 85718
- Recruiting
University of Arizona College of Medicine - Tucson
Tucson, Arizona, 85724
- Recruiting
Focus Clinical Research
West Hills, California, 91307
Poland10 sites, 9 recruiting
- Recruiting
Synexus Polska Sp. z o. o. Oddział w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537
- Recruiting
NZOZ Wielospacjalistyczna Poradnia Lekarska Synapsis
Katowice, Silesian Voivodeship, 40-123
- Recruiting
Novo-Med Zieliński i Wsp. Sp.J.
Katowice, Silesian Voivodeship, 40-650
- Recruiting
Pratia MCM Kraków
Krakow, Lesser Poland Voivodeship, 30-727
- Recruiting
Centrum Medyczne Plejady
Krakow, Maloplski, 30-363
- Recruiting
NZOZ NEUROMED M. and M. Nastaj Spółka Partnerska
Lublin, 20-064
- Suspended
Terra Centrum Leczenia
Sopot, Pomeranian Voivodeship, 81-735
- Recruiting
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, 01-684
- Recruiting
TZ Clinical Research powered by Pratia
Warsaw, Masovian Voivodeship, 02-172
- Recruiting
Neurosphera
Warsaw, Masovian Voivodeship, 02-952
Australia7 sites, 7 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
The Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, 6009
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3052
Bulgaria5 sites, 5 recruiting
- Recruiting
Multiprofile Hospital for Active Treatment PULS
Blagoevgrad, 2700
- Recruiting
Medical Center (MC) Academica
Pleven, 5809
- Recruiting
Medical Center - Teodora EOOD
Rousse, 7012
- Recruiting
University Multiprofile Hospital for Active Treatment Aleksandrovska, Clinic for Neurology Diseases
Sofia, Sofia-Grad, 1431
- Recruiting
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry "Sveti Naum" EAD
Sofia, 1113
Hungary2 sites, 2 recruiting
- Recruiting
Flash Clinic
Budapest, 1125
- Recruiting
SE, Idegsebeszeti es Neurointervencios Klinika, Epilepszia Centrum
Budapest, 1145
About this study
Official title: 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.
Read the 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.
- Conditions
- Focal Onset Seizures
- Being tested
- SPN-817, Placebo
- Keywords
- focal seizures, focal epilepsy, Phase 2, anti-seizure medication
- Medical subject headings
- Seizures, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPN-817Drug
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
PlaceboDrug
Placebo, bid
| Study group | Role | What they receive |
|---|---|---|
| SPN-817 | Experimental | SPN-817, bid Receives: Drug: SPN-817 |
| Placebo | Placebo comparator | Placebo, bid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance Period
Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline
Measured: Baseline and Maintenance Period (Maintenance Week 1-14)
Secondary outcomes (5)
Proportion of subjects experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline
Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline.
Measured: Baseline and Maintenance Period (Maintenance Week 1-14)
PCH from baseline in focal onset seizure frequency per 28 days over the entire Treatment Period
Percent change in 28-day frequency of focal seizures during the entire Treatment Period (Titration Period + Maintenance Period) relative to baseline
Measured: 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
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.
Measured: Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
Longest seizure-free interval over the entire Treatment Period
The longest intervals in days between two seizures during the entire Treatment Period.
Measured: Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14
Incidence of treatment-emergent adverse events (TEAEs)
The percent of subjects who took at least one dose of SPN-817 and reported at least one adverse event during SPN-817 treatment.
Measured: Baseline through Titration Week 1 up to Week 10, Maintenance Weeks 1-14, and Tapering Period up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start30 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Onset SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maciej Gasior, MD, PhD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798896
- Sponsor's protocol ID
- 817P203
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No