Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06798896

PHASE2

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

Sponsor: Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2024-12-30

Completion Date

2027-08

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Focal Onset Seizures

Interventions

DRUG

SPN-817

SPN-817 starting at 0.25 mg bid up to 4.00 mg bid

DRUG

Placebo

Placebo, bid

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.

Locations (63)

Xenoscience

Phoenix, Arizona, United States

Banner University Medical Center-Phoenix

Phoenix, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

University of Arizona College of Medicine - Tucson

Tucson, Arizona, United States

Clinical Trials, Inc

Little Rock, Arkansas, United States

Clinical Research Institute

Los Angeles, California, United States

Access Community Clinical Trials

Mission Hills, California, United States

University of California, Irvine

Orange, California, United States

Focus Clinical Research

West Hills, California, United States

Yale University

New Haven, Connecticut, United States

Northwest Florida Clinical Research Group, LLC

Gulf Breeze, Florida, United States

Ilumina Medical Research

Kissimmee, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Research Institute of Orlando, LLC

Orlando, Florida, United States

Medsol Clinical Research Center

Port Charlotte, Florida, United States

Cleveland Clinic Florida Martin Health

Port Saint Lucie, Florida, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

University of Louisville Physicians

Louisville, Kentucky, United States

Neurocare of Louisiana

Covington, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Mid Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Wayne State University - Detroit Medical Center

Detroit, Michigan, United States

Northeast Regional Epilepsy Group - Hackensack

Hackensack, New Jersey, United States

Hackensack Meridian Health Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Dent Neurologic Institute

Amherst, New York, United States

Northwell Health - Lenox Hill

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Asheville Neurology Specialists

Asheville, North Carolina, United States

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, United States

Neurology Institute Epilepsy Center of Cleveland Clinic

Cleveland, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Advanced Neurology Epilepsy and Sleep Center/ANESC Research

El Paso, Texas, United States

Stryde Research

Frisco, Texas, United States

UT Health Houston

Houston, Texas, United States

Medstar Health Research Institute

McLean, Virginia, United States

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

The Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, Australia

University Multiprofile Hospital for Active Treatment Aleksandrovska, Clinic for Neurology Diseases

Sofia, Sofia-Grad, Bulgaria

Multiprofile Hospital for Active Treatment PULS

Blagoevgrad, Bulgaria

Medical Center (MC) Academica

Pleven, Bulgaria

Medical Center - Teodora EOOD

Rousse, Bulgaria

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry "Sveti Naum" EAD

Sofia, Bulgaria

Flash Clinic

Budapest, Hungary

SE, Idegsebeszeti es Neurointervencios Klinika, Epilepszia Centrum

Budapest, Hungary

Pratia MCM Kraków

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne Plejady

Krakow, Maloplski, Poland

Centrum Medyczne NeuroProtect

Warsaw, Masovian Voivodeship, Poland

TZ Clinical Research powered by Pratia

Warsaw, Masovian Voivodeship, Poland

Neurosphera

Warsaw, Masovian Voivodeship, Poland

Synexus Polska Sp. z o. o. Oddział w Gdyni

Gdynia, Pomeranian Voivodeship, Poland

Terra Centrum Leczenia

Sopot, Pomeranian Voivodeship, Poland

NZOZ Wielospacjalistyczna Poradnia Lekarska Synapsis

Katowice, Silesian Voivodeship, Poland

Novo-Med Zieliński i Wsp. Sp.J.

Katowice, Silesian Voivodeship, Poland

NZOZ NEUROMED M. and M. Nastaj Spółka Partnerska

Lublin, Poland

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)