A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04622293|
Recruitment Status : Not yet recruiting
First Posted : November 9, 2020
Last Update Posted : March 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome Myalgic Encephalomyelitis||Drug: Solriamfetol Oral Tablet [Sunosi] Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Estimated Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Those who are receiving solriamfetol will receive 37.5 mg, 75 mg, or 150 mg. Patients will begin at a 75 mg dose and then after three days titrate up or down as needed, determined by consultation visits with primary investigator. Solriamfetol will be taken orally.
Drug: Solriamfetol Oral Tablet [Sunosi]
Solriamfetol will be given to those participants placed in the experimental group, and given at three possible dosages ( 37.5 mg, 75 mg, and 150 mg). Solriamfetol is already FDA approved for treatment of excessive daytime sleepiness, and has been found safe to use. In this study, we are determining if solriamfetol can also be used to treat chronic fatigue syndrome.
Other Name: Sunosi
Placebo Comparator: Placebo
Those who are not receiving solriamfetol will receive the placebo drug, which will be encapsulated in matching capsules to reduce any bias or speculation with participants.
A placebo encapsulated to look the same as the experimental drug will be given to the control group.
- Fatigue Symptom Inventory (FSI) [ Time Frame: Up to 8 weeks ]This measure has excellent internal reliability and good convergent validity and construct validity. The FSI has been demonstrated to effectively discriminate between patients with clinically significant fatigue and those that do not. Its psychometric properties have repeatedly been demonstrated to support its use in research for fatigue symptoms.
- BRIEF-A [ Time Frame: Up to 8 weeks ]The BRIEF-A is a comprehensive measure of executive functioning, examining 8 cognitive tasks. It is non-diagnosis specific and applicable for use with a variety of cognition-impacting conditions
- Clinical Global Impression (CGI-I and CGI-S) [ Time Frame: Up to 8 weeks ]The CGI-S measures severity at baseline and the CGI-I measures improvement. It is commonly utilized across FDA-regulated trials. The Patient Global Impression (PGI-I and PGI-S) measure was created to tack efficacy in studies involving incontinence, and has become widely used in clinical research to capture change in functioning from the perspective of the patient.
- Young CFS Scale [ Time Frame: Up to 8 weeks ]Due to the strong research and clinical need for a better self-report diagnostic screening tool for ME/CFS that can also reflect changes in symptoms due to treatment, this trial will assist in the development of a proposed measure of ME/CFS, entitled the "Young CFS Scale." Part of the validation of this measure will be analysis of its relationship with other measures in measuring ME/CFS in clinical samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622293
|Contact: Celeste N Zabel, MPHemail@example.com|
|Contact: Richard Powell, Ph.Dfirstname.lastname@example.org|
|Principal Investigator:||Joel Young, MD||Rochester Center for Behavioral Medicine|