Trials by therapeutic agent

Sodium Oxybate clinical trials

3 post-viral trials on ClinicalTrials.gov · updated October 2026

Last updated 07 October 2026 from ClinicalTrials.gov. Trial statuses are refreshed automatically; check the registry record for the latest status and contact details.

3 trials0 open to enrolment1 completed1 terminated1 withdrawn

All interventional trials in our ClinicalTrials.gov extract that list Sodium Oxybate as an intervention, across ME/CFS (3). 0 are currently open to enrolment and 1 has completed. Read the OSMF evidence profile for Sodium Oxybate for literature, mechanism and dosing context.

Intervention names are normalised from the registry's own arm labels, so the same compound can appear under a brand name, a generic name or a combination; check the full agent index for related entries.

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Not medical advice. This page is an automatically compiled index of entries on ClinicalTrials.gov. Listing here is not an endorsement of any trial, sponsor or treatment, and trial status can change between our refreshes. Always confirm details on ClinicalTrials.gov and discuss participation with your own clinician.

Completed (1)

CompletedPhase 4 NCT02055898
Sponsor: Imperial College London (Academic / non-profit / other)
Intervention(s): Sodium Oxybate
Condition group: ME/CFS
Start: Apr 2014  |  Primary completion: Aug 2015  |  Enrollment: 13 (actual)
Record last updated: Nov 2020

The investigators wish to investigate whether enhancement of SWS, which is seen after a drug called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function, specifically sleepiness and mental performance. This is a safe and well-tolerated drug that is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.

View on ClinicalTrials.gov ↗

Terminated (1)

TerminatedPhase 4 NCT00498485
Sponsor: University of Medicine and Dentistry of New Jersey (Academic / non-profit / other)
Intervention(s): Sodium Oxybate
Condition group: ME/CFS
Start: May 2007  |  Primary completion: Dec 2008  |  Enrollment: 17 (actual)
Record last updated: May 2016

Chronic fatigue syndrome is a disabling illness for which there is no specific treatment. As a group, CFS patients have disturbed sleep with frequent arousals and the sense of not having slept upon awakening. Xyrem (Sodium oxybate) is known to improve deep sleep and so may reduce the sleep disturbances of CFS leading to better sleep with less fatigue.

View on ClinicalTrials.gov ↗

Withdrawn (1)

WithdrawnPhase 4 NCT01584934
Sponsor: University Hospital, Ghent (Academic / non-profit / other)
Intervention(s): Sodium Oxybate
Condition group: ME/CFS
Start: Jun 2013  |  Primary completion: Jun 2015
Record last updated: Dec 2022

Chronic fatigue syndrome (CFS) is a disabling, unexplained disorder characterized by physical and mental exhaustion. Complaints of disturbed and unrefreshing sleep are very common in CFS patients, however, the relationship between (disturbed) sleep quality and fatigue is still not fully elucidated.

View on ClinicalTrials.gov ↗

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Open the trial's ClinicalTrials.gov record (the "View on ClinicalTrials.gov" button), read the Eligibility Criteria and Contacts and Locations sections, and contact the study team listed there. Trials only enrol at the sites shown in the record, so check whether a site is near you or whether the study is remote/decentralised. Your own clinician can help you judge whether a trial is a sensible option and may need to provide medical records.

What do the trial phases mean?

Early Phase 1 / Phase 1 studies test safety and dosing in a small group. Phase 2 studies look for a signal of benefit in a larger group and keep checking safety. Phase 3 studies are large confirmatory trials designed to show whether a treatment works well enough for approval. Phase 4 studies follow approved treatments after they reach the market. "Phase not applicable" is used by the registry for behavioural, device, rehabilitation and other non-drug interventions.

Does the Open Source Medicine Foundation run these trials?

No. OSMF does not sponsor, run or recruit for any trial on this page. We compile public registry entries from ClinicalTrials.gov so patients and clinicians can find them in one place. For questions about a specific study, contact the sponsor or study team listed on its ClinicalTrials.gov record.

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Cite this page
Open Source Medicine Foundation. Sodium Oxybate clinical trials for Long COVID, ME/CFS and post-viral illness (3 trials, updated October 2026). Research Tracker, 07 October 2026. https://research.opensourcemed.info/trials/by-agent/sodium-oxybate.html
Underlying dataset (JSON, CC BY 4.0): https://research.opensourcemed.info/data/clinical_trials/clinical_trials_current.json. Source records: ClinicalTrials.gov.

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