Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT04622293
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Sponsor:
Rochester Center for Behavioral Medicine
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Placebo-Controlled, Single-Center, Flexible Titration Study Evaluating the Efficacy of Solriamfetol in Treating Fatigue and Cognitive Symptoms in Adults Aged 18-65 Years With a Diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: