A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

NCT04622293 | Completed Phase 4 FDA Drug

• 1 other identifier: 102044RCT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Keywords

Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Outcome Measures

Primary Outcomes (1)

• Fatigue Symptom Inventory (FSI)

  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.

  Up to 8 weeks

Secondary Outcomes (1)

• BRIEF-A

  Up to 8 weeks

Other Outcomes (2)

• Clinical Global Impression (CGI-I and CGI-S)

  Up to 8 weeks

• Young CFS Scale

  Up to 8 weeks

Study Arms (2)

Solriamfetol

EXPERIMENTAL

Those who are receiving solriamfetol will receive 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]

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Solriamfetol Oral Tablet [Sunosi] DRUG

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.

Also known as: Sunosi

Solriamfetol

Placebo DRUG

A placebo encapsulated to look the same as the experimental drug will be given to the control group.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must meet IOM 2015 diagnostic criteria for ME/CFS. These criteria will be assessed by obtaining clinical histories and using appropriate symptom checklists.
• All subjects must be 18-65 years of age at the time of consent.
• All sexually active males or females of child baring potential must agree to practice two different methods of birth control or remain abstinent during the course of the trial. Methods of birth control or contraception will be logged. Male and female contraception will be continued throughout the study and for 30 days after study discontinuation. Women of childbearing potential must test negative for pregnancy at the Screening Visit.
• All subjects must be able to swallow intact tablets.
• Subjects, in the opinion of the investigator, must be able to understand and comply with protocol requirements- including assessments, prescribed dosage regimens, and discontinuation of concomitant medications.
• All subjects must have a minimum level of intellectual functioning without evidence of significant general intellectual deficit, as determined by the primary investigator. Specific learning disorders will not be considered general intellectual deficits.
• All subjects must be able to provide written, personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before completing any study related procedures.
• All subjects must be fluent in English and have a degree of understanding sufficient to communicate suitably with the primary investigator and the study coordinator.
• Subjects must have a negative drug screen for cocaine and other illicit (illegal for recreational use in the State of Michigan) drugs excluding cannabis due to legality of cannabis in Michigan. Subjects with a positive drug screen for confirmed prescription or over the counter use of medications will require the necessary washout per PI instruction. Subjects who test positive for any prohibited medications per PI maybe permitted with PI approval. Re-tests will not be allowed for a positive screen of an illicit drug.
• All subjects must score at or above a 4 on the CGIS-S at screening.

You may not qualify if:

• Subjects must not be immediate family of the Investigator or others directly affiliated with the study.
• Subjects must not have received treatment with a drug that has not received regulatory approval or participated in a clinical trial within 30 days prior to screening.
• Subjects must not have medical complications arising from being severely underweight or overweight.
• Subjects must not have a current co-morbid psychiatric disorder that is uncontrolled and associated with significant symptoms or that requires a prohibited medication or behavioral modification program. Co-morbid psychiatric diagnoses will be assessed during a psychiatric intake and scoring of the MINI.
• Subjects must not currently be considered a suicide risk (as determined by the primary investigator and assessed by the C-SSRS). They must not have made a suicide attempt within the past two years. They cannot have current suicidal ideation with intent or plan to act, or current suicidal behavior.
• Subjects must not have a history of substance abuse or drug dependence according to DSM-5 criteria currently or within one year prior to study participation, excluding nicotine and caffeine. This is determined through clinical history and symptom checklist to be obtained at visit 1.
• Subjects must not test positive for an illicit substance at the time of screening.
• Subjects must not have a serious chronic or acute unstable medical condition or illness, including cardiovascular, hepatic, respiratory, or hematologic illness, narrow angle glaucoma, or other unstable medical or psychiatric conditions that in the opinion of the Investigator would compromise participation or would likely lead to hospitalization during the duration of the study. Subjects with a history of intellectual impairment or a severe learning disability are also excluded.
• Subjects must not have a history of seizure disorder (other than infantile febrile seizures), any tic disorder, current diagnosis and/or family history of Tourette's disorder.
• Subjects must not have a history of organic heart disease including coronary artery disease, past myocardial infarction, angina, arrhythmias, congestive heart failure, valvular heart disease and congenital heart disease.
• Subjects must not be likely (as assessed by the primary investigator) to add psychotropic medications, apart from their current regimen or the drug under study, to their treatment regimen during the course of the study.
• Subjects must not have been previously enrolled in this study.
• Subjects must not anticipate relocation outside the geographic range of the investigative site during participation in the study. Subjects must not have extended travel plans inconsistent with the recommended visit intervals.
• Have a known hypersensitivity, allergy intolerance or documented history of non-responsivity to NDRIs or similar medication.
• Subjects who, in the opinion of the Investigator, are unsuitable in any other way to participate in the study.

Sponsors & Collaborators

• Rochester Center for Behavioral Medicine: lead

Study Sites (1)

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Related Publications (7)

• Hann DM, Jacobsen PB, Azzarello LM, Martin SC, Curran SL, Fields KK, Greenberg H, Lyman G. Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory. Qual Life Res. 1998 May;7(4):301-10. doi: 10.1023/a:1024929829627.

  PMID: 9610214 BACKGROUND

• Donovan KA, Jacobsen PB, Small BJ, Munster PN, Andrykowski MA. Identifying clinically meaningful fatigue with the Fatigue Symptom Inventory. J Pain Symptom Manage. 2008 Nov;36(5):480-7. doi: 10.1016/j.jpainsymman.2007.11.013. Epub 2008 May 20.

  PMID: 18495413 BACKGROUND

• Donovan KA, Jacobsen PB. The Fatigue Symptom Inventory: a systematic review of its psychometric properties. Support Care Cancer. 2010 Feb;19(2):169-85. doi: 10.1007/s00520-010-0989-4. Epub 2010 Sep 8.

  PMID: 20824482 BACKGROUND

• Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

  PMID: 20526405 BACKGROUND

• Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.

  PMID: 30471270 BACKGROUND

• Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.

  PMID: 12861145 BACKGROUND

• Young JL, Powell RN, Powell A, Welling LLM, Granata L, Saal J. Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment. J Psychopharmacol. 2025 Nov;39(11):1268-1276. doi: 10.1177/02698811251368371. Epub 2025 Sep 16.

  PMID: 40958377 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Young, MD

  Rochester Center for Behavioral Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 9, 2020
• Study Start: April 27, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)