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

Inclusion Criteria:

• All subjects must meet IOM 2015 diagnostic criteria for ME/CFS. These criteria willbe assessed by obtaining clinical histories and using appropriate symptomchecklists.

• 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 topractice two different methods of birth control or remain abstinent during thecourse of the trial. Methods of birth control or contraception will be logged. Maleand female contraception will be continued throughout the study and for 30 daysafter study discontinuation. Women of childbearing potential must test negative forpregnancy 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 complywith protocol requirements- including assessments, prescribed dosage regimens, anddiscontinuation of concomitant medications.

• All subjects must have a minimum level of intellectual functioning without evidenceof significant general intellectual deficit, as determined by the primaryinvestigator. Specific learning disorders will not be considered generalintellectual deficits.

• All subjects must be able to provide written, personally signed and dated informedconsent to participate in the study in accordance with the International Conferenceon Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicableregulations before completing any study related procedures.

• All subjects must be fluent in English and have a degree of understanding sufficientto communicate suitably with the primary investigator and the study coordinator.

• Subjects must have a negative drug screen for cocaine and other illicit (illegal forrecreational use in the State of Michigan) drugs excluding cannabis due to legalityof cannabis in Michigan. Subjects with a positive drug screen for confirmedprescription or over the counter use of medications will require the necessarywashout per PI instruction. Subjects who test positive for any prohibitedmedications per PI maybe permitted with PI approval. Re-tests will not be allowedfor a positive screen of an illicit drug.

• All subjects must score at or above a 4 on the CGIS-S at screening.

Exclusion Criteria:

• Subjects must not be immediate family of the Investigator or others directlyaffiliated with the study.

• Subjects must not have received treatment with a drug that has not receivedregulatory approval or participated in a clinical trial within 30 days prior toscreening.

• Subjects must not have medical complications arising from being severely underweightor overweight.

• Subjects must not have a current co-morbid psychiatric disorder that is uncontrolledand associated with significant symptoms or that requires a prohibited medication orbehavioral modification program. Co-morbid psychiatric diagnoses will be assessedduring a psychiatric intake and scoring of the MINI.

• Subjects must not currently be considered a suicide risk (as determined by theprimary investigator and assessed by the C-SSRS). They must not have made a suicideattempt within the past two years. They cannot have current suicidal ideation withintent or plan to act, or current suicidal behavior.

• Subjects must not have a history of substance abuse or drug dependence according toDSM-5 criteria currently or within one year prior to study participation, excludingnicotine and caffeine. This is determined through clinical history and symptomchecklist 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 orillness, including cardiovascular, hepatic, respiratory, or hematologic illness,narrow angle glaucoma, or other unstable medical or psychiatric conditions that inthe opinion of the Investigator would compromise participation or would likely leadto hospitalization during the duration of the study. Subjects with a history ofintellectual impairment or a severe learning disability are also excluded.

• Subjects must not have a history of seizure disorder (other than infantile febrileseizures), any tic disorder, current diagnosis and/or family history of Tourette'sdisorder.

• Subjects must not have a history of organic heart disease including coronary arterydisease, 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 addpsychotropic 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 theinvestigative site during participation in the study. Subjects must not haveextended travel plans inconsistent with the recommended visit intervals.

Subjects must not be taking any excluded medications that cannot be discontinued prior to beginning treatment with study medication. Subjects' medical history will be reviewed by the PI and current prescription regimen will be reviewed for CNS stimulants and noradrenergic and dopaminergic medications. The PI will determine on a case by case basis if concomitant use of the patient's current prescriptions would affect response to solriamfetol and reasoning for inclusion or exclusion will be documented. Stimulant medications will be excluded (methylphenidate or amphetamine based).

• Have a known hypersensitivity, allergy intolerance or documented history ofnon-responsivity to NDRIs or similar medication.

• Subjects who, in the opinion of the Investigator, are unsuitable in any other way toparticipate in the study.

• Subjects who have taken an MAOI within 14 of the beginning of the study.

• Subjects currently taking a medication regime that would otherwise likely interferewith the efficacy of solriamfetol or the integrity of study results as determined ona case by case basis by the primary investigator.