RECRUITING

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

Conditions

Focal Onset Seizures focal seizures focal epilepsy Phase 2 anti-seizure medication

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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

Quick Facts

Study Start:2024-12-30

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06798896

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 eDiary data collection) and no more than a consecutive 21-day period that was seizure free. To be eligible for the study, participants must comply with the eDiary on at least 90% of the days of baseline data collection;	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 are cholinergic or anticholinergic. 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.

Inclusion Criteria

Exclusion 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 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 eDiary data collection) and no more than a consecutive 21-day period that was seizure free. To be eligible for the study, participants must comply with the eDiary on at least 90% of the days of baseline data collection;

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 are cholinergic or anticholinergic.
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.

Contacts and Locations

Study Contact

Neeti Mehta, PhD

CONTACT

240-403-5838

namehta@supernus.com

Navid Saeidi, MS

CONTACT

240-403-5328

nsaeidi@supernus.com

Principal Investigator

Himanshu Upadhyaya, MBBS, MS, MBA

STUDY_DIRECTOR

Supernus Pharmaceuticals, Inc.

Study Locations (Sites)

Medsol Clinical Research Center

Port Charlotte, Florida, 33952

United States

Collaborators and Investigators

Sponsor: Supernus Pharmaceuticals, Inc.

Himanshu Upadhyaya, MBBS, MS, MBA, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-12-30

Study Completion Date2026-10

Study Record Updates

Study Start Date2024-12-30

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

focal seizures
focal epilepsy
Phase 2
anti-seizure medication

Additional Relevant MeSH Terms

Focal Onset Seizures