Who is sponsoring NCT04622293?

NCT04622293 is sponsored by Rochester Center for Behavioral Medicine.

What drugs are being tested in NCT04622293?

Interventions in NCT04622293: Solriamfetol Oral Tablet [Sunosi], Placebo.

What condition does NCT04622293 study?

NCT04622293 studies Chronic Fatigue Syndrome, Myalgic Encephalomyelitis.

Is NCT04622293 still recruiting?

NCT04622293 is currently completed. Last updated 6 April 2025.

Last reviewed 2025-04-06 · How we verify

NCT04622293

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 6 April 2025

What this trial tests

Phase 4 trial testing Solriamfetol Oral Tablet [Sunosi] in Chronic Fatigue Syndrome in 44 participants. Completed in 1 December 2024.

Timeline

27 April 2021

Primary endpoint
1 September 2024

1 December 2024

Quick facts

Lead sponsor	Rochester Center for Behavioral Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	44
Start date	27 April 2021
Primary completion	1 September 2024
Estimated completion	1 December 2024
Sites	1 location across United States

Drugs / interventions tested

Solriamfetol Oral Tablet [Sunosi] — full drug profile →
Placebo

Conditions studied

Chronic Fatigue Syndrome — all drugs for Chronic Fatigue Syndrome →
Myalgic Encephalomyelitis — all drugs for Myalgic Encephalomyelitis →

Sponsor

Rochester Center for Behavioral Medicine — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment.
Young JL, Powell RN, Powell A, Welling LLM, et al · · 2025 · cited 1× · PMID 40958377 · DOI 10.1177/02698811251368371

Verify or expand the search:

Other recruiting trials for Chronic Fatigue Syndrome

Currently open trials in the same condition.

NCT07009691 — Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS · NA · recruiting
NCT06585254 — tVNS in Long COVID-19 · NA · recruiting
NCT05741112 — The Long COVID-19 Wearable Device Study · NA · recruiting
NCT05967052 — Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitati · Phase 2 · recruiting
NCT05525598 — Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders · NA · recruiting

Other Rochester Center for Behavioral Medicine trials

Trials by the same sponsor.

NCT06248229 — A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04622293 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rochester Center for Behavioral Medicine
Last refreshed: 6 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04622293.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing