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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Xyrem Placebo Clear all
Completed Phase 2 Interventional Results available

Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor

NCT00598078
View directory record Official record
Conditions
Essential Tremor
Interventions
Sodium Oxybate, Placebo
Drug · Other
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
50 Years to 75 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Bingham Farms, Michigan
Source: ClinicalTrials.gov public record
Updated Jan 22, 2012 · Synced Sep 7, 2026, 7:33 AM EDT
Withdrawn Phase 2 Interventional

The Effect of Sodium Oxybate on Sleep Architecture

NCT00744393
View directory record Official record
Conditions
Mechanically Ventilated ICU Patients
Interventions
sodium oxybate, placebo
Drug
Lead sponsor
Tufts Medical Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 22, 2018 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 2 Interventional Results available

Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia

NCT00087555
View directory record Official record
Conditions
Fibromyalgia
Interventions
Xyrem (sodium oxybate) oral solution, Placebo
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
195 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
20
States / cities
Scottsdale, Arizona • Beverly Hills, California • Los Angeles, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jan 23, 2012 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional

Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)

NCT06525077
View directory record Official record
Conditions
Idiopathic Hypersomnia
Interventions
FT218, Placebo
Drug · Other
Lead sponsor
Avadel
Industry
Eligibility
18 Years to 75 Years
Enrollment
157 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
7
States / cities
Boulder, Colorado • Winter Park, Florida • Stockbridge, Georgia + 4 more
Source: ClinicalTrials.gov public record
Updated May 10, 2026 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional Results available

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

NCT00066170
View directory record Official record
Conditions
Narcolepsy
Interventions
Xyrem, Xyrem Placebo, Modafinil at established dose, Modafinil (Placebo)
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
231 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2004
U.S. locations
36
States / cities
Phoenix, Arizona • Fullerton, California • Los Angeles, California + 29 more
Source: ClinicalTrials.gov public record
Updated Dec 28, 2011 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional

Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients

NCT00049803
View directory record Official record
Conditions
Narcolepsy
Interventions
sodium oxybate
Drug
Lead sponsor
Orphan Medical
Industry
Eligibility
16 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2004
U.S. locations
37
States / cities
Birmingham, Alabama • La Jolla, California • Stanford, California + 31 more
Source: ClinicalTrials.gov public record
Updated Jun 23, 2005 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 4 Interventional Results available

Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

NCT00086281
View directory record Official record
Conditions
Obstructive Sleep Apnea Syndrome
Interventions
Xyrem (X), Zolpidem (Z), Modafinil (M), Placebo (P)
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
1
States / cities
St. Petersburg, Florida
Source: ClinicalTrials.gov public record
Updated Feb 23, 2012 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

NCT00803023
View directory record Official record
Conditions
Fibromyalgia
Interventions
Sodium Oxybate, Sodium Oxybate & 6 Tablets, Sodium Oxybate & 8 Tablets, Sodium Oxybate Oral Solution (6 grams)
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
129 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2010
U.S. locations
32
States / cities
Phoenix, Arizona • Anaheim, California • Fair Oaks, California + 26 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2011 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Physiological, Behavioral and Subjective Effects of Drugs (GHB)

NCT00058955
View directory record Official record
Conditions
Sedative Abuse
Interventions
sodium oxybate, triazolam and pentobarbital
Drug
Lead sponsor
Orphan Medical
Industry
Eligibility
18 Years to 50 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2003 – 2005
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 9, 2008 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional Results available

Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

NCT02720744
View directory record Official record
Conditions
Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
Interventions
FT218, Placebo
Drug
Lead sponsor
Avadel
Industry
Eligibility
16 Years and older
Enrollment
212 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
38
States / cities
Anniston, Alabama • Auburn, Alabama • Birmingham, Alabama + 32 more
Source: ClinicalTrials.gov public record
Updated Mar 21, 2022 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional Results available

A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy

NCT02221869
View directory record Official record
Conditions
Narcolepsy With Cataplexy
Interventions
Xyrem
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
7 Years to 17 Years
Enrollment
106 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
17
States / cities
Long Beach, California • Orange, California • Redwood City, California + 14 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2019 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional Results available

A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.

NCT00423813
View directory record Official record
Conditions
Fibromyalgia
Interventions
placebo, Xyrem®
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
573 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
71
States / cities
Auburn, Alabama • Birmingham, Alabama • Montgomery, Alabama + 61 more
Source: ClinicalTrials.gov public record
Updated Jan 23, 2012 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional Results available

A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

NCT03030599
View directory record Official record
Conditions
Narcolepsy With Cataplexy
Interventions
JZP-258, Placebo
Drug · Other
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
201 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
12
States / cities
Orange, California • Stanford, California • Boulder, Colorado + 9 more
Source: ClinicalTrials.gov public record
Updated Nov 11, 2020 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 4 Interventional Results available

Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

NCT04006925
View directory record Official record
Conditions
REM Sleep Behavior Disorder, Parkinson Disease
Interventions
Sodium Oxybate, Placebo
Drug · Other
Lead sponsor
Stanford University
Other
Eligibility
40 Years to 85 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated May 9, 2023 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor

NCT03292458
View directory record Official record
Conditions
Spasmodic Dysphonia, Voice Tremor
Interventions
Sodium Oxybate
Drug
Lead sponsor
Kristina Simonyan
Other
Eligibility
21 Years to 80 Years
Enrollment
117 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Dec 29, 2025 · Synced Sep 7, 2026, 7:33 AM EDT
Terminated Phase 4 Interventional Results available

Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

NCT00498485
View directory record Official record
Conditions
Chronic Fatigue Syndrome
Interventions
Placebo, Sodium Oxybate
Drug
Lead sponsor
University of Medicine and Dentistry of New Jersey
Other
Eligibility
21 Years to 65 Years
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Newark, New Jersey
Source: ClinicalTrials.gov public record
Updated May 18, 2016 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 3 Interventional Results available

A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia

NCT00371137
View directory record Official record
Conditions
Fibromyalgia
Interventions
Xyrem®, Placebo
Drug
Lead sponsor
Jazz Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
548 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
70
States / cities
Anniston, Alabama • Huntsville, Alabama • Phoenix, Arizona + 60 more
Source: ClinicalTrials.gov public record
Updated Dec 28, 2011 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 2 Interventional Results available

Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

NCT00383643
View directory record Official record
Conditions
Sleep Initiation and Maintenance Disorders
Interventions
zolpidem tartrate, sodium oxybate, Matching Placebos
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years to 75 Years
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated May 31, 2017 · Synced Sep 7, 2026, 7:33 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Enhancing Slow Wave Sleep With Sodium Oxybate

NCT00506974
View directory record Official record
Conditions
Sleep
Interventions
sodium oxybate
Drug
Lead sponsor
St. Luke's Hospital, Chesterfield, Missouri
Other
Eligibility
18 Years to 50 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2008
U.S. locations
1
States / cities
Chesterfield, Missouri
Source: ClinicalTrials.gov public record
Updated Sep 25, 2008 · Synced Sep 7, 2026, 7:33 AM EDT