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

NCT06798896 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2025-02-06

No results posted yet for this study

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

Interventions

DRUG

SPN-817

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

DRUG

Placebo

Placebo, bid

Sponsors & Collaborators

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Himanshu Upadhyaya, MBBS, MS, MBA · Supernus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798896 on ClinicalTrials.gov