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

NCT06798896 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 817P203
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Focal Onset Seizures

Keywords

focal seizures; focal epilepsy; Phase 2; anti-seizure medication

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline and Maintenance Period (Maintenance Week 1-14)

• PCH from baseline in focal onset seizure frequency per 28 days over the entire Treatment Period

  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

  Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14

• Longest seizure-free interval over the entire Treatment Period

  Baseline through Titration Week 1 up to Week 10 and Maintenance Weeks 1-14

• Incidence of adverse events (AEs)

  Baseline through Titration Week 1 up to Week 10, Maintenance Weeks 1-14, and Tapering Period up to Week 4

Study Arms (2)

SPN-817

EXPERIMENTAL

SPN-817, bid

Drug: SPN-817

Placebo

PLACEBO COMPARATOR

Placebo, bid

Drug: Placebo

Interventions

SPN-817 DRUG

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

SPN-817

Placebo DRUG

Placebo, bid

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 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;

You may not qualify 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 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;
• 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 are cholinergic or anticholinergic.
• 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.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (1)

Medsol Clinical Research Center

Port Charlotte, Florida, 33952, United States

RECRUITING

MeSH Terms

Conditions

Seizures; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy; Brain Diseases; Central Nervous System Diseases

Study Officials

• Himanshu Upadhyaya, MBBS, MS, MBA

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Supernus Clinical Trials

CONTACT

240-403-5838; clinicaltrials@supernus.com

Navid Saeidi, MS

CONTACT

240-403-5328; nsaeidi@supernus.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 29, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

US (1)