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Solriamfetol for Chronic Fatigue Syndrome

Phase 4

Waitlist Available

Led By Joel Young, MD

Research Sponsored by Rochester Center for Behavioral Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All subjects must be 18-65 years of age at the time of consent.

All subjects must be able to swallow intact tablets.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

Study Summary

This trial tests if a drug can help treat fatigue for people with chronic fatigue syndrome. Subjects are randomly given the drug or a placebo. Results will determine the drug's effectiveness.

Who is the study for?

Adults aged 18-65 with a diagnosis of Chronic Fatigue Syndrome as per IOM 2015 criteria, able to swallow tablets and provide informed consent. Participants must practice strict birth control if applicable, have no severe chronic conditions or psychiatric disorders, not use illicit drugs (except cannabis in Michigan), and not be on certain medications that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing Solriamfetol's effectiveness against fatigue in Chronic Fatigue Syndrome patients over an 8-week period. It's a double-blind study where participants are randomly assigned to receive either Solriamfetol or a placebo without knowing which one they're getting.See study design

What are the potential side effects?

While specific side effects for this trial aren't listed, common side effects of Solriamfetol may include headache, nausea, insomnia, anxiety, decreased appetite and dry mouth. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I can swallow pills without any issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Personality inventories

Secondary outcome measures

BRIEF-A

Other outcome measures

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

Young CFS Scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SolriamfetolExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rochester Center for Behavioral MedicineLead Sponsor

3 Previous Clinical Trials

102 Total Patients Enrolled

Joel Young, MDPrincipal InvestigatorRochester Center for Behavioral Medicine

2 Previous Clinical Trials

845 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04622293 — Phase 4

Chronic Fatigue Syndrome Research Study Groups: Solriamfetol, Placebo

Chronic Fatigue Syndrome Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04622293 — Phase 4

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04622293 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How reassuring are the safety profiles of Solriamfetol?

"The current evaluation of solriamfetol's safety is a 3, as this medication has already been confirmed to be safe and effective in Phase 4 trials."

Answered by AI

Are any enrollees being accepted at this point in time for the clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical trial is still searching for participants after being posted on April 27th 2021 and updated lastly on July 26th 2023. 44 patients are needed at a single site in order to complete the study."

Answered by AI

What is the size of the cohort receiving this treatment?

"Affirmative. According to clinicaltrials.gov records, this medical trial is actively looking for participants and opened on April 27th 2021. The most recent revision was made July 26th 2023, with 44 patients needed from a single site."

Answered by AI

Is Solriamfetol undergoing assessment in additional research trials?

"Presently, 3 trials for Solriamfetol are conducting research. None of these investigations have advanced to Phase 3 yet. The majority of the studies occur in Rochester Hills, Michigan; however, there are other testing sites across the country as well."

Answered by AI

Is the age of participants in this study restricted to individuals under 35?

"This clinical trial seeks participants between 18 and 75 years of age."

Answered by AI

To which demographic does this clinical trial offer eligibility?

"This clinical trial is searching for 44 individuals in the 18-75 year old bracket that are suffering from chronic fatigue syndrome. In order to be eligible, patients must meet IOM 2015 diagnostic criteria as well as demonstrate a degree of intellectual capability without significant general deficit and possess sufficient English fluency to communicate with researchers. Furthermore, participants must agree to use two forms of contraception or remain abstinent throughout the course of the study, have intact swallowing abilities, provide informed written consent according to GCP guidelines and pass drug screenings excluding cannabis due to local legality requirements and scoring at least 4 on the CGIS-S screening test."

Answered by AI

Recent research and studies

European PsychiatryJournal

Patient Centric Measures for a Patient Centric Era: Agreement and Convergent Between Ratings on the Patient Global Impression of Improvement (PGI-I) Scale and the Clinical Global Impressions – Improvement (CGI-S) Scale in Bipolar and Major Depressive Disorder

Mohebbi, M., S. Dodd, O.M. Dean, and M. Berk. 2018. “Patient Centric Measures for a Patient Centric Era: Agreement and Convergent Between Ratings on the Patient Global Impression of Improvement (PGI-I) Scale and the Clinical Global Impressions – Improvement (CGI-S) Scale in Bipolar and Major Depressive Disorder”. European Psychiatry. Cambridge University Press (CUP). doi:10.1016/j.eurpsy.2018.05.006.

clinicaltrials.govStudy

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

Joel L. Young, M.D. 2021. "A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04622293.

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