Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
Public ClinicalTrials.gov record NCT00049803. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) With Placebo for the Treatment of Narcolepsy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00049803
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2000 (Type not available)
- Primary completion
- Not listed
- Completion
- Apr 2004 (Type not available)
- Last update posted
- Jun 24, 2005
2000 – 2004
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Disorders Center of Alabama, Inc. | Birmingham | Alabama | 35213 | — |
| Pacific Sleep Medicine Services | La Jolla | California | 92037-1205 | — |
| Stanford Sleep Disorders Clinic | Stanford | California | 94305 | — |
| St. Petersburg Sleep Disorders Center | St. Petersburg | Florida | 33707 | — |
| Sleep Disorders Center of Georgia | Atlanta | Georgia | 30342 | — |
| Sleep Disorders Center--Division of Neurology | Evanston | Illinois | 60201 | — |
| Peoria Pulmonary Associates, Ltd. | Peoria | Illinois | 61603 | — |
| The Center for Sleep and Wake Disorders/Midwest Neurology | Danville | Indiana | 46122 | — |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46804 | — |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46805 | — |
| Chest Medicine Associates DBA/Sleep Medicine Specialists | Louisville | Kentucky | 40217 | — |
| LSU Health Science Center | Shreveport | Louisiana | 71130 | — |
| Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| Center for Sleep Diagnostics | Newton | Massachusetts | 02459 | — |
| Department of Neurology | Worcester | Massachusetts | 01608 | — |
| Washington University -- Sleep Medicine Center | St Louis | Missouri | 63108 | — |
| Sleep/Wake Center 7N2 -- Bellevue Hospital Center | New York | New York | 10016 | — |
| The Sleep Center - Community General Hospital | Syracuse | New York | 13215 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | — |
| Central Carolina Neurology & Sleep | Salisbury | North Carolina | 28144 | — |
| CSC Research -- Grove City Sleep Diagnostic Center | Grove City | Ohio | 43123 | — |
| Southwest Cleveland Sleep Center | Middleburg Heights | Ohio | 44130 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Clinical Pharmaceutical Trials, Inc. | Tulsa | Oklahoma | 74104 | — |
| Rhode Island Hospital - Division of Pulmonary, Sleep and Critical Care Medicine | Providence | Rhode Island | 02903 | — |
| Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Charleston Pulmonary Associates PA | Charleston | South Carolina | 29403 | — |
| Low Country Lung and Critical Care PA | Charleston | South Carolina | 29406-7108 | — |
| Palmetto Baptist Medical Center Sleep Disorders Center | Columbia | South Carolina | 29201 | — |
| Charleston Pulmonary Associates PA | Mt. Pleasant | South Carolina | 29464 | — |
| Sleep Medicine Assoc PLLC -- Summit Medical Center | Hermitage | Tennessee | 37076 | — |
| The Houston Sleep Center | Houston | Texas | 77024 | — |
| Sleep Medicine Associates of Texas | Plano | Texas | 75093 | — |
| Sleep Disorders Center -- Eastern Virginia Medical School -- Sentara General Hospital | Norfolk | Virginia | 23507 | — |
| VCU Health System MCV Hospitals - Sleep Disorders Center | Richmond | Virginia | 23235 | — |
| Swedish Sleep Medicine Institute | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00049803, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 24, 2005 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00049803 live on ClinicalTrials.gov.