Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
Public ClinicalTrials.gov record NCT00107809. 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
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL ® (Modafinil) Treatment (100, 200, and 400 mg/Day) in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by: * mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6 or early termination) * the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination).
Study identification
- NCT ID
- NCT00107809
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2004 (Type not available)
- Primary completion
- Not listed
- Completion
- Sep 2005 (Type not available)
- Last update posted
- May 9, 2014
2004 – 2005
United States locations
- U.S. sites
- 60
- U.S. states
- 28
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Robert Doekel, Jr., M.D. | Birmingham | Alabama | 35213 | — |
| Derek Loewy, Ph.D. | Tucson | Arizona | 85712 | — |
| Stuart Quan, M.D. | Tucson | Arizona | 85724 | — |
| Joseph McCarty, M.D. | Fort Smith | Arkansas | 72913 | — |
| John L. Carroll, M.D. | Little Rock | Arkansas | 72202 | — |
| Julie Thompson-Dobkin, D.O. | Huntington Beach | California | 92648 | — |
| Mark Buchfuhrer, M.D. | Long Beach | California | 90806 | — |
| Yury Furman, M.D. | Los Angeles | California | 90048 | — |
| Stuart Menn, M.D. | Palm Springs | California | 92262 | — |
| Richard Shubin, M.D. | Pasadena | California | 91105 | — |
| Lawrence Sher, M.D. | Rolling Hills Estates | California | 90274 | — |
| Milton K. Erman, M.D. | San Diego | California | 92121 | — |
| Stephen Brooks, M.D. | San Francisco | California | 94109 | — |
| Paul Haberman, M.D. | Santa Monica | California | 90404 | — |
| Jed Black, M.D. | Stanford | California | 94305 | — |
| Amerigo Padilla, M.D. | Miami | Florida | 33173 | — |
| Martin A. Cohn, M.D. | Naples | Florida | 34110 | — |
| D. Alan Lankford, Ph.D. | Atlanta | Georgia | 30342 | — |
| Gary Montgomery, M.D. | Atlanta | Georgia | 30342 | — |
| Jerry Silverboard, M.D. | Atlanta | Georgia | 30342 | — |
| Stephen H. Sheldon, D.O., FAAP | Chicago | Illinois | 60614 | — |
| Michael Kohrman, M.D. | Chicago | Illinois | 60637 | — |
| Anna Ivanenko, M.D., Ph.D. | Maywood | Illinois | 60153 | — |
| Henry Lahmeyer, M.D. | Northfield | Illinois | 60093 | — |
| James Cook, M.D. | Danville | Indiana | 46122 | — |
| William Leeds, D.O. | Topeka | Kansas | 66606 | — |
| Karen Waters, M.D. | Louisville | Kentucky | 40202 | — |
| Margaret Ann Springer, M.D. | Shreveport | Louisiana | 71103 | — |
| Helene A. Emsellem, M.D. | Chevy Chase | Maryland | 20815 | — |
| Marc Raphaelson, M.D. | Frederick | Maryland | 21702 | — |
| Daniela Minecan, M.D. | Ann Arbor | Michigan | 48109 | — |
| George Zureikat, M.D. | Flint | Michigan | 48503 | — |
| Pradeep Sahota, M.D. | Columbia | Missouri | 65212 | — |
| William Torch, M.D., MS | Reno | Nevada | 89502 | — |
| Kathleen Ryan, M.D. | Mount Laurel | New Jersey | 08054 | — |
| Sushmita Mikkilineni, M.D. | New Brunswick | New Jersey | 08903 | — |
| Monroe Karetzky, M.D. | Newark | New Jersey | 07112 | — |
| Lee Brooks, M.D. | Princeton | New Jersey | 08540 | — |
| Marc Seelagy, M.D. | Trenton | New Jersey | 08629 | — |
| Gary Zammit, M.D. | New York | New York | 10025 | — |
| James Lee, M.D. | Charlotte | North Carolina | 28226 | — |
| Raouf Amin, MD | Cincinnati | Ohio | 45229 | — |
| Martin Scharf, Ph.D. | Cincinnati | Ohio | 45246 | — |
| Markus H. Schmidt, M.D., Ph.D. | Dublin | Ohio | 43017 | — |
| Michael Neeb, Ph.D. | Toledo | Ohio | 43608 | — |
| William C. Orr, Ph.D. | Oklahoma City | Oklahoma | 73112 | — |
| Jorg Pahl, M.D. | Oklahoma City | Oklahoma | 73118 | — |
| Dainis Irbe, M.D. | Eugene | Oregon | 97401 | — |
| William Pistone, M.D. | Allentown | Pennsylvania | 18104 | — |
| Jeffery Gould, M.D. | Bethlehem | Pennsylvania | 18015 | — |
| Guillermo Borrero, M.D. | Clairton | Pennsylvania | 15025 | — |
| Judith Owens, M.D., MPH | Providence | Rhode Island | 02903 | — |
| Richard Bogan, M.D., FCCP | Columbia | South Carolina | 29201 | — |
| Julie Jacques, D.O. | Morristown | Tennessee | 37814 | — |
| John Hudson, M.D. | Austin | Texas | 78756 | — |
| David Sperry, M.D. | Dallas | Texas | 75230 | — |
| Todd J. Swick, M.D. | Houston | Texas | 77024 | — |
| Jerry J. Tomasovic, M.D. | San Antonio | Texas | 78258 | — |
| James M. Ferguson, M.D. | Salt Lake City | Utah | 84107 | — |
| Ralph A. Pascualy, M.D. | 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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00107809, 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 May 9, 2014 · Synced Oct 30, 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 NCT00107809 live on ClinicalTrials.gov.