Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
Public ClinicalTrials.gov record NCT00066170. 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, Double-Dummy, Placebo-Controlled, Parallel-Group, Multi-Center Trial Comparing the Effects of Orally Administered Xyrem (Sodium Oxybate) and Modafinil With Placebo in Treatment of Daytime Sleepiness in Narcolepsy
Study identification
- NCT ID
- NCT00066170
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Jazz Pharmaceuticals
- Industry
- Enrollment
- 231 participants
Conditions and interventions
Conditions
Interventions
- Modafinil (Placebo) Drug
- Modafinil at established dose Drug
- Xyrem Drug
- Xyrem Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 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
- Mar 31, 2003
- Primary completion
- Jun 30, 2004
- Completion
- Oct 31, 2004
- Last update posted
- Dec 28, 2011
2003 – 2004
United States locations
- U.S. sites
- 36
- U.S. states
- 18
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85006 | — |
| St. Jude Medical Center -- Sleep Disorders Institute | Fullerton | California | 92835 | — |
| Pacific Sleep Medicine Services, Inc. | Los Angeles | California | 90048 | — |
| Neuro-Therapeutics, Inc. | Pasadena | California | 91105 | — |
| Pacific Sleep Medicine Services, Inc. | San Diego | California | 92121 | — |
| Stanford Sleep Disorders Clinic | Stanford | California | 94305 | — |
| Clinical Research Group of St. Petersburg, Inc. | St. Petersburg | Florida | 33707 | — |
| Peoria Pulmonary Associates, Ltd | Peoria | Illinois | 61603 | — |
| The Center for Sleep and Wake Disorders/Midwest Neurology | Danville | Indiana | 46122 | — |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | — |
| Community Research & Sleep Management Institute | Crestview Hills | Kentucky | 41017 | — |
| Chest Medicine Associates DBA -- Sleep Medicine Specialists | Louisville | Kentucky | 40217 | — |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| Sleep Disorders Center -- Union Hospital of Cecil County | Elkton | Maryland | 21921 | — |
| Sleep Medicine Associates of Maryland | Towson | Maryland | 21204 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Washington University Sleep Center | St Louis | Missouri | 63108 | — |
| New Jersey Neuroscience Institute at JFK Medical Center | Edison | New Jersey | 08818 | — |
| Sleep Disorders Center of Rochester | Rochester | New York | 14618 | — |
| Strong Sleep Disorders Center | Rochester | New York | 14618 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | — |
| ALL-TRIALS Clinical Research, LLC -- Summit Sleep Disorder | Winston-Salem | North Carolina | 27103 | — |
| Cincinnati Clinic & Sleep Management Institute | Cincinnati | Ohio | 45219 | — |
| Community Research Management Associates,Inc. | Cincinnati | Ohio | 45219 | — |
| CSC Research -- Grove City Sleep Diagnostic Center | Grove City | Ohio | 43123 | — |
| Lehigh Valley Hospital Sleep Disorders Center | Allentown | Pennsylvania | 18105 | — |
| Capital Region Sleep Disorder Center | Carlisle | Pennsylvania | 17013 | — |
| Center for Sleep Medicine | Lafayette Hill | Pennsylvania | 19444 | — |
| Lowcountry Lung and Critical Care, PA | Charleston | South Carolina | 29406-7108 | — |
| SleepMed of South Carolina | Columbia | South Carolina | 29220 | — |
| SDHRF Clinical Research Center | Sioux Falls | South Dakota | 57104 | — |
| Sioux Valley Clinic -- Pulmonary | Sioux Falls | South Dakota | 57105 | — |
| Sleep Disorders Center | Sioux Falls | South Dakota | 57105 | — |
| Bhupesh Dihenia, MD | Lubbock | Texas | 79410 | — |
| SLEEP WALKER -- Sleep Disorders Center & Neurodiagnostics--Lung Diagnostics, Ltd. | San Antonio | Texas | 78229 | — |
| Vermont Medical Sleep Disorders Center, Inc. | Essex Junction | Vermont | 05452 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00066170, 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 Dec 28, 2011 · Synced May 5, 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 protocol, eligibility criteria, and contact information for NCT00066170 live on ClinicalTrials.gov.