Chronic Fatigue SyndromePhase 4NCT04622293
A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
A Phase 4 study testing Solriamfetol Oral Tablet [Sunosi] in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Rochester Center for Behavioral Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- What is being tested?
- Solriamfetol Oral Tablet [Sunosi]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 1 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
About this study
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
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.
Read the 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.
- Being tested
- Solriamfetol Oral Tablet [Sunosi], Placebo
- Keywords
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol Oral Tablet [Sunosi]Drug
Also called Sunosi
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.
PlaceboDrug
A placebo encapsulated to look the same as the experimental drug will be given to the control group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
Secondary outcomes (1)
BRIEF-A
The BRIEF-A is a comprehensive measure of executive functioning, examining 8 cognitive tasks. It is non-diagnosis specific and applicable for use with a variety of cognition-impacting conditions
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start27 Apr 2021
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rochester Center for Behavioral Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel L. Young, M.D., Rochester Center for Behavioral Medicine
- Investigators
- Joel Young, MD, Principal investigator, Rochester Center for Behavioral Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622293
- Sponsor's protocol ID
- 102044RCT
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2020
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data that was collected during this study.
Publications
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.
PubMed 9610214Donovan 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.
PubMed 18495413Donovan 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.
PubMed 20824482Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405Strollo 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.
PubMed 30471270Yalcin 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.
PubMed 12861145Young 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.
PubMed 40958377
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04622293
- Acronym / sponsor ID
- 102044RCT
- Keywords
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rochester Center for Behavioral MedicineUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol | Experimental | Drug: Solriamfetol Oral Tablet [Sunosi]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. |
| Placebo | Placebo comparator | Drug: PlaceboThose 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solriamfetol Oral Tablet [Sunosi]Also: SunosiSolriamfetol 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. | Drug | Solriamfetol |
| PlaceboA placebo encapsulated to look the same as the experimental drug will be given to the control group. | Drug | Placebo |
Primary outcome
Fatigue Symptom Inventory (FSI)
Time frame: Up to 8 weeks
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.
1 secondary outcome
BRIEF-A
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 9610214Hann 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.
- Background: PubMed 18495413Donovan 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.
- Background: PubMed 20824482Donovan 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.
- Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Background: PubMed 30471270Strollo 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.
- Background: PubMed 12861145Yalcin 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.
- Derived from this study: PubMed 40958377Young 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data that was collected during this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Young, MD principal investigator
Rochester Center for Behavioral Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solriamfetol Oral Tablet [Sunosi] in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Rochester Center for Behavioral Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Symptom Inventory (FSI) (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04622293, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.