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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 is a Phase 4 study that has completed, run by Rochester Center for Behavioral Medicine. The registered enrollment target is 44 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04622293
The ClinicalTrials.gov registry entry for NCT04622293 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rochester Center for Behavioral Medicine, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04622293 reports 0 study locations.
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.
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