AXS-07 Emerge Study | AXSM Message Board Posts


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Msg  1655 of 1771  at  11/24/2023 11:54:24 AM  by

biobetter

The following message was updated on 11/24/2023 11:58:29 AM.

 In response to msg 1654 by  thecroup
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Re: AXS-07 Emerge Study

 
There is also a Sunosi trial that is nearing the finish line. This might get a mention on the Sunosi Dec 7th call.
 

Study Overview

Brief Summary
This study is an 8-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of solriamfetol in the treatment of fatigue symptoms in adult patients with chronic fatigue syndrome. Subjects will be randomized to a solriamfetol group or placebo group. The investigators will utilize an intent to treat model and impute data. The overall goal of this study is to determine the efficacy and effectiveness of solriamfetol for treating chronic fatigue syndrome.
 
Detailed Description

This will be an 8-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of solriamfetol in the treatment of fatigue symptoms in adult patients (18-65) with a diagnosis of ME/CFS. Subjects will be randomized (1:1) to a solriamfetol (flexible titration dosing) group (n=17 to 22) or placebo group (n = 17 to 22). The investigators will utilize an intent to treat model and impute data, if statistically feasible, from dropouts utilizing a MNAR (missing not at random) approach.

The trial involves primary, secondary, exploratory and safety/tolerability objectives.

Primary objective: Evaluate IMP efficacy in treating ME/CFS fatigue symptoms

Primary endpoint: Difference in means at week 8 between treatment and control groups as measured by the Fatigue Symptom Inventory.

Secondary objective: Evaluate IMP efficacy in treating ME/CFS cognitive symptoms.

Secondary endpoint: Difference in means between treatment and control groups as measured by the BRIEF-A.

Exploratory objective: Evaluate IMP efficacy in treating symptoms related to overall clinical severity/distress of patients with ME/CFS and common co-occurring conditions of ME/CFS.

Exploratory endpoints: Differences in means between treatment and control groups as measured by the Fibromyalgia Impact Questionnaire, the Sheehan Disability Scale, the Clinical Global Impression measure, and the Patient Global Impression measure.

Safety and tolerability objective: Evaluate the safety and tolerability of IMP for the treatment of patients with a diagnosis of ME/CFS.

Safety and tolerability endpoints: Frequency and severity of AEs, changes in vital signs: blood pressure, pulse rate, weight, and physical exams. Subjects will undergo a 12-lead ECG exam, Urine Drug Screens, and Urine Pregnancy Test. Suicidality will be assessed utilizing the Columbia Suicidality Severity Rating Scale.

 
Study Start (Actual2021-04-27
Primary Completion (Estimated2023-12-01
Study Completion (Estimated2024-02-01
Enrollment (Estimated44
Study Type Interventional
Phase Phase 4
 
 
 


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