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

NCT ID: NCT06798896

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2026-10-31

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.

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 (8 mg oral [PO]) will be taken prophylactically approximately 30 minutes before each SM dose (ie, BID) during the first 5 weeks of dose titration as an antiemetic; after the first 5 weeks, ondansetron may be taken as needed as either a preventative or therapeutic antiemetic. After the target dose of 3.0-4.0 mg BID is reached, participants will enter the Maintenance Period (14 weeks). 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SPN-817

SPN-817, bid

Group Type: EXPERIMENTAL

SPN-817

Intervention Type: DRUG

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

Placebo

Placebo, bid

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, bid

Interventions

SPN-817

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

Intervention Type: DRUG

Placebo

Placebo, bid

Intervention Type: DRUG

Eligibility Criteria

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 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;

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Himanshu Upadhyaya, MBBS, MS, MBA

Role: STUDY_DIRECTOR

Supernus Pharmaceuticals, Inc.

Locations

Medsol Clinical Research Center

Port Charlotte, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Supernus Clinical Trials

Role: CONTACT

clinicaltrials@supernus.com

240-403-5838

Navid Saeidi, MS

Role: CONTACT

nsaeidi@supernus.com

240-403-5328

Facility Contacts

Maria Vasconcelos, RN

Role: primary

mvasconcelos@medsolcrc.com

941.623.9744

Other Identifiers

817P203

Identifier Type: -

Identifier Source: org_study_id