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Last Updated: January 26, 2023

CLINICAL TRIALS PROFILE FOR SODIUM OXYBATE


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All Clinical Trials for Sodium Oxybate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00049803 ↗ Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients Completed Orphan Medical Phase 3 2000-12-01 The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week period. During the trial, narcolepsy symptoms will be evaluated. Participants are allowed to continue using stimulant medications at constant doses during the study. A total of 1 to 3 daytime visits in addition to 4 overnight visits to the sleep center will be required to complete the study.
NCT00066170 ↗ Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy Completed Jazz Pharmaceuticals Phase 3 2003-04-01 This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.
NCT00086281 ↗ Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients Completed Jazz Pharmaceuticals Phase 4 2003-11-01 To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Oxybate

Condition Name

Condition Name for Sodium Oxybate
Intervention Trials
Narcolepsy 8
Fibromyalgia 5
Sleep 4
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Condition MeSH

Condition MeSH for Sodium Oxybate
Intervention Trials
Narcolepsy 12
Disorders of Excessive Somnolence 10
Sleepiness 6
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Clinical Trial Locations for Sodium Oxybate

Trials by Country

Trials by Country for Sodium Oxybate
Location Trials
United States 199
Canada 13
France 9
United Kingdom 5
Spain 4
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Trials by US State

Trials by US State for Sodium Oxybate
Location Trials
California 13
New York 12
Ohio 10
Missouri 10
Florida 10
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Clinical Trial Progress for Sodium Oxybate

Clinical Trial Phase

Clinical Trial Phase for Sodium Oxybate
Clinical Trial Phase Trials
Phase 4 14
Phase 3 12
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Sodium Oxybate
Clinical Trial Phase Trials
Completed 34
Recruiting 5
Terminated 3
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Clinical Trial Sponsors for Sodium Oxybate

Sponsor Name

Sponsor Name for Sodium Oxybate
Sponsor Trials
Jazz Pharmaceuticals 16
State University of New York - Upstate Medical University 3
National Institute on Deafness and Other Communication Disorders (NIDCD) 2
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Sponsor Type

Sponsor Type for Sodium Oxybate
Sponsor Trials
Other 44
Industry 26
NIH 7
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