Axsome Therapeutics Inc. ((AXSM)) announced an update on their ongoing clinical study.
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Study Overview: Axsome Therapeutics Inc. is conducting a Phase 3 trial titled ‘A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder.’ The study, known as SUSTAIN, aims to evaluate the effectiveness and safety of solriamfetol in treating adults suffering from excessive sleepiness due to shift work disorder, a condition affecting many in the workforce.
Intervention/Treatment: The trial is testing solriamfetol, a drug designed to combat excessive sleepiness. Participants receive either 150 mg or 300 mg doses of solriamfetol or a placebo, administered daily over a period of up to 12 weeks.
Study Design: This is an interventional study with a randomized, parallel assignment. It employs a double-blind method, meaning neither participants nor investigators know who receives the drug or placebo. The primary goal is treatment efficacy.
Study Timeline: The study began on August 21, 2024, with a primary completion date yet to be announced. The latest update was submitted on January 21, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
Market Implications: This study could significantly impact Axsome Therapeutics’ stock performance. Positive results may boost investor confidence and position the company as a leader in treating shift work disorder, potentially affecting competitors in the sleep disorder treatment market.
The study is currently recruiting, with further details available on the ClinicalTrials portal.