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

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Brief Title

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

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

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Fatigue Symptom Inventory (FSI)

Secondary Outcome

 BRIEF-A

Condition

Chronic Fatigue Syndrome

Intervention

Solriamfetol Oral Tablet [Sunosi]

Study Arms / Comparison Groups

 Solriamfetol
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

44

Start Date

April 1, 2021

Completion Date

January 1, 2022

Primary Completion Date

August 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.

        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 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.

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

          -  Subjects currently taking a medication regime that would otherwise likely interfere
             with the efficacy of solriamfetol or the integrity of study results as determined on a
             case by case basis by the primary investigator.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Joel Young, MD, 2486088800, [email protected]



Administrative Informations


NCT ID

NCT04622293

Organization ID

102044RCT


Responsible Party

Principal Investigator

Study Sponsor

Rochester Center for Behavioral Medicine


Study Sponsor

Joel Young, MD, Principal Investigator, Rochester Center for Behavioral Medicine


Verification Date

March 2021