Supernus Pharmaceuticals ((SUPN)) announced an update on their ongoing clinical study.
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Study Overview: The RENAISSANCE 2 study, officially titled ‘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,’ aims to assess the effectiveness and safety of SPN-817 in treating focal onset seizures in adults. This study is significant as it explores a potential new treatment option for a condition that affects many individuals worldwide.
Intervention/Treatment: The study tests SPN-817, an experimental drug, against a placebo. SPN-817 is administered in doses ranging from 0.25 mg to 4.00 mg twice daily, aiming to reduce the frequency and severity of seizures.
Study Design: This is an interventional Phase 2 study with a randomized, parallel assignment model. It employs quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocation. The primary purpose is treatment-focused, aiming to determine the drug’s efficacy and safety.
Study Timeline: The study began on January 16, 2025, with the latest update submitted on February 3, 2025. These dates are crucial as they mark the study’s progression and ensure that the information remains current for stakeholders.
Market Implications: This study update could positively impact Supernus Pharmaceuticals’ stock performance and investor sentiment, as successful results may lead to a new treatment option for focal onset seizures. In a competitive pharmaceutical landscape, advancements in treatment options can enhance a company’s market position and attract investor interest.
The study is currently recruiting, with further details available on the ClinicalTrials portal.