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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.

Must not have

Subjects must not have medical complications arising from being severely underweight or overweight.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have health issues from being severely under or overweight.

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I have no history of heart disease.

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I do not have any serious or unstable health conditions that could affect my participation.

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I have never had seizures, tic disorders, or Tourette's in my family.

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I am allergic or do not respond to certain depression medications.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Personality inventories

Secondary study objectives

BRIEF-A

Other study objectives

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

Young CFS Scale

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 7Eligibility criteria met