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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00066170
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 231 participants
Conditions and interventions
Conditions
Interventions
- Xyrem Drug
- Xyrem Placebo Drug
- Modafinil at established dose Drug
- Modafinil (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
- Apr 2003 (Type not available)
- Primary completion
- Jul 2004 (Actual)
- Completion
- Nov 2004 (Actual)
- Last update posted
- Dec 29, 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 29, 2011 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00066170 live on ClinicalTrials.gov.