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NCT04622293 · ClinicalTrials.gov registry record · Phase 4
A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
A Phase 4 study, sponsored by Rochester Center for Behavioral Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT04622293: Completed Phase 4 study, sponsored by Rochester Center for Behavioral Medicine.
NCT04622293 is a Phase 4 study that has completed, run by Rochester Center for Behavioral Medicine. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04622293, a Phase 4 study, has completed, sponsored by Rochester Center for Behavioral Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Solriamfetol Oral Tablet [Sunosi]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2024-12-01 |
| Phase | Phase 4 |
What the finished NCT04622293 record still lists
NCT04622293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04622293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04622293 about?
NCT04622293 is a clinical study titled "A Trial of Solriamfetol in the Treatment 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 g...
What is the current status of trial NCT04622293?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2021-04-27. Estimated completion is 2024-12-01.
What interventions are being tested in trial NCT04622293?
The interventions under investigation include: Placebo (DRUG), Solriamfetol Oral Tablet [Sunosi] (DRUG).
Who is sponsoring clinical trial NCT04622293?
This trial is sponsored by Rochester Center for Behavioral Medicine, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04622293's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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